{ "$schema": "https://www.conphora.com/schemas/regulation-page.json", "code": "MED", "locale": "en", "url": "https://www.conphora.com/regulations/med/", "json": "https://www.conphora.com/regulations/med.json", "summaryPdf": "https://www.conphora.com/regulations/med/summary.pdf", "dateModified": "2026-09-12", "regulation": { "code": "MED", "name": "Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC", "shortName": "Marine Equipment Directive", "reference": "Directive 2014/90/EU", "celex": "32014L0090", "eurlex": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090", "actType": "Directive", "category": "Maritime & Transport", "inForce": "2014-09-17", "appliesFrom": "2016-09-18", "changing": true, "video": "regulation-med" }, "answer": "The Marine Equipment Directive requires ship equipment needing flag State approval under SOLAS, MARPOL or COLREG to meet international standards, proven by notified bodies and the wheel mark, binding manufacturers, importers and distributors. It has applied since 18 September 2016; the current equipment list is Implementing Regulation (EU) 2026/1434 of 30 June 2026, in force since 31 August 2026.", "description": "MED guide: the Marine Equipment Directive, which equipment on EU-flagged ships it covers, the wheel mark and electronic tag, the notified-body conformity routes, the annual implementing regulation, key dates and how to comply.", "enforcedBy": "Member States carry out market surveillance of marine equipment under the EU market surveillance framework (Article 25 still cites Chapter III of Regulation (EC) No 765/2008, and Articles 12(10) and 26(1) still cite Articles 19 and 21 of it; Regulation (EU) 2019/1020 deleted all of Chapter III, Articles 15 to 29, so those references are read as Regulation (EU) 2019/1020 from 16 July 2021, and the directive is point 58 of its Annex I), and their flag State administrations verify the equipment on board when they issue, endorse or renew the ships' convention certificates; checks may cover documents and wheel-marked equipment before or after it is placed on board. In Denmark, Søfartsstyrelsen (the Danish Maritime Authority) implements the directive through executive order nr. 422 of 17 May 2016 on equipment in ships, issued under lov om sikkerhed til søs, is the notifying authority for notified bodies with DANAK assessing and monitoring them, can order marketing stopped and products recalled, may use the control powers of the product and market surveillance act, can detain ships lacking prescribed equipment and can order any breach corrected within a deadline. The toolkit is corrective action, withdrawal or recall within a period commensurate with the risk, prohibition or restriction of making available or placing on board, orders to end formal non-compliance such as a missing wheel mark or declaration, notified-body suspension or withdrawal of certificates, and national penalties, which in Denmark are fines or imprisonment of up to one year, or two years in aggravated cases.", "keyDates": [ { "date": "2014-07-23", "label": "Directive 2014/90/EU adopted by the European Parliament and the Council, replacing Council Directive 96/98/EC", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · title and signature block after Art. 42" }, { "date": "2014-09-17", "label": "Entry into force, the twentieth day after publication in OJ L 257 of 28 August 2014; the five-year delegation of power to the Commission runs from this date", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 41 and Art. 37(2)" }, { "date": "2016-09-18", "label": "Member States apply their transposing laws; Directive 96/98/EC repealed; equipment placed on board an EU ship from this date must meet the international instruments applicable when it is placed on board; the wheel mark becomes the reference for equivalence when a ship transfers to an EU flag", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 4(1), Art. 7(1), Art. 39(1) and Art. 40(1)" }, { "date": "2018-04-08", "label": "Delegated Regulation (EU) 2018/414 in force: the items of marine equipment that may benefit from electronic tagging are listed", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R0414 · Art. 1 and Art. 2, OJ L 75 of 19 March 2018" }, { "date": "2018-05-10", "label": "Implementing Regulation (EU) 2018/608 in force: technical criteria for RFID and data-matrix electronic tags that supplement or replace the wheel mark", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R0608 · Art. 1 to Art. 4, OJ L 101 of 20 April 2018" }, { "date": "2021-08-11", "label": "Delegated Directive (EU) 2021/1206 in force: Annex III, point 19 now requires testing laboratories used by notified bodies to meet EN ISO/IEC 17025:2017; transposition by 31 January 2022", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021L1206 · Art. 1 to Art. 3, OJ L 261 of 22 July 2021" }, { "date": "2022-02-28", "label": "Danish executive order nr. 251 of 21 February 2022 in force, transposing Delegated Directive (EU) 2021/1206 into executive order nr. 422 of 17 May 2016 on equipment in ships", "source": "https://www.retsinformation.dk/eli/lta/2022/251 · § 1 and § 2" }, { "date": "2024-08-01", "label": "Regulation (EU) 2024/1689 (Artificial Intelligence Act) in force; its Article 105 adds Article 8(5) to the directive on AI systems that are safety components of marine equipment", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689 · Art. 105 and Art. 113, OJ L of 12 July 2024" }, { "date": "2026-08-02", "label": "Article 8(5) applies: when pursuing standards or adopting technical specifications for AI systems that are safety components, the Commission takes into account Chapter III, Section 2 of the AI Act", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689 · Art. 113; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0090-20260802 · Art. 8(5)" }, { "date": "2026-08-31", "label": "Commission Implementing Regulation (EU) 2026/1434 in force, the fortieth day after publication on 22 July 2026: the current list of marine equipment items with their requirements, testing standards and conformity assessment modules; Implementing Regulation (EU) 2025/1533 repealed", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1434 · Art. 1, Art. 2 and Art. 4" }, { "date": "2027-09-04", "label": "End of the transitional period for items first inserted by Implementing Regulation (EU) 2024/1975: equipment complying with national type-approval requirements in force before 4 September 2024 may be placed on the market and on board until this date", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1434 · Art. 3(1)" }, { "date": "2028-09-23", "label": "End of the transitional period for items first inserted by Implementing Regulation (EU) 2025/1533: equipment complying with national type-approval requirements in force before 23 September 2025 may be placed on the market and on board until this date", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1434 · Art. 3(2)" } ], "amendedBy": [ { "reference": "Commission Delegated Directive (EU) 2021/1206", "celex": "32021L1206", "date": "2021-08-11", "summary": "Adopted on 30 April 2021 under Article 36 and published in OJ L 261 of 22 July 2021, the delegated directive replaced the reference to EN ISO/IEC 17025:2005 in point 19 of Annex III with EN ISO/IEC 17025:2017, the standard that testing laboratories used by conformity assessment bodies must meet; Member States had to transpose it by 31 January 2022, which Denmark did with executive order nr. 251 of 21 February 2022.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021L1206 · Art. 1 to Art. 3; https://www.retsinformation.dk/eli/lta/2022/251 · § 1" }, { "reference": "Regulation (EU) 2024/1689 (Artificial Intelligence Act)", "celex": "32024R1689", "date": "2024-08-01", "summary": "The AI Act of 13 June 2024, published on 12 July 2024 and in force on 1 August 2024, added Article 8(5) to the directive through its Article 105: for AI systems that are safety components within the meaning of the AI Act, the Commission must take into account the high-risk requirements of Chapter III, Section 2 of the AI Act when pursuing international standards under Article 8(1) and when adopting technical specifications and testing standards under Article 8(2) and (3); the amendment applies from 2 August 2026, and the directive is listed in Section B of Annex I to the AI Act.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689 · Art. 105, Art. 113 and Annex I, Section B, point 16; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0090-20260802 · Art. 8(5)" } ], "scope": { "appliesTo": [ "Equipment placed or to be placed on board an EU ship, that is a ship flying the flag of a Member State and falling within the SOLAS, MARPOL or COLREG conventions, for which the international instruments require the approval of the flag State administration, regardless of where the ship is when the equipment is fitted", "The items listed in the Annex to Implementing Regulation (EU) 2026/1434: life-saving appliances, marine pollution prevention equipment, fire protection equipment, navigation equipment, radio-communication equipment, equipment required under COLREG 72, other safety equipment and equipment under SOLAS Chapter II-1", "Equipment made available on the Union market in the course of a commercial activity, whether for payment or free of charge, and equipment delivered to be placed on board EU ships", "The economic operators in the chain: manufacturers, authorised representatives, importers and distributors", "Equipment already on board, which Member States must keep in line with the international instruments applicable to it, and equipment on a non-EU ship transferred to the flag of a Member State" ], "derived": [ "Where equipment within the directive also falls under other Union law, it is subject only to this directive for the purpose of enhancing safety at sea and preventing marine pollution through uniform application of the international instruments (Art. 3(2))", "The design, construction and performance requirements and testing standards for each item are those of the international instruments as implemented by the Commission's implementing regulation, applying from the placing-on-the-market and placing-on-board dates it indicates (Art. 4 and Art. 35(2))", "An importer or distributor that places equipment on the market or on board under its own name or trademark, or modifies equipment already placed on the market in a way that may affect compliance, is treated as the manufacturer (Art. 14(3))", "Member States may not prohibit the placing on the market or on board of compliant wheel-marked equipment, nor refuse or withhold the related ship certificates (Art. 6)", "A flag State administration may allow equipment without a wheel mark on board only in the cases of technical innovation, testing or evaluation, or exceptional circumstances such as replacement in a port outside the Union. Technical innovation and testing or evaluation each require a certificate issued by the flag Member State that is carried with the equipment at all times (Art. 30(3) and Art. 31(a)); in exceptional circumstances the equipment is instead accompanied by documentation from an IMO Member State party to the relevant conventions, and a certificate — the interim certificate of approval — is required only where wheel-marked equipment is shown to be unavailable on the market (Art. 32(2) and Art. 32(7))" ], "categories": [ { "id": "life-saving-appliances", "label": "Life-saving appliances (lifeboats, liferafts, lifejackets, immersion suits, launching appliances, distress signals)" }, { "id": "marine-pollution-prevention-equipment", "label": "Marine pollution prevention equipment (oily-water separators, oil discharge monitors, sewage treatment plants, incinerators)" }, { "id": "fire-protection-equipment", "label": "Fire protection equipment (fire-resisting divisions, extinguishing systems, fire detection, hoses, nozzles, firefighter's outfits)" }, { "id": "navigation-equipment", "label": "Navigation equipment (compasses, radar, ECDIS, AIS, echo sounders, voyage data recorders)" }, { "id": "radio-communication-equipment", "label": "Radio-communication equipment (VHF, MF/HF, satellite EPIRBs, SARTs, GMDSS installations)" }, { "id": "colreg-solas-other-safety-equipment", "label": "Equipment required under COLREG 72, other safety equipment and equipment under SOLAS Chapter II-1 (navigation lights, loading instruments, machinery and electrical items listed in the implementing regulation)" }, { "id": "equipment-not-subject-to-med-certification", "label": "Items listed for information only as not subject to MED certification, or components not listed in the implementing regulation" }, { "id": "non-eu-flag-ship-equipment", "label": "Equipment for a ship that does not fly the flag of an EU Member State" }, { "id": "non-convention-ship-equipment", "label": "Equipment for ships outside the SOLAS, MARPOL and COLREG conventions (small fishing vessels, pleasure craft, inland or domestic craft not covered)" }, { "id": "pre-2016-approved-equipment", "label": "Equipment approved under Directive 96/98/EC and placed on board before 18 September 2016" }, { "id": "exceptional-replacement-equipment", "label": "Equipment placed on board without a wheel mark for technical innovation, testing or evaluation, or replacement in a port outside the Union" }, { "id": "spare-parts-and-replacements", "label": "Spare parts, consumables and replacement of an item already on board an EU ship" } ], "roles": [ { "id": "manufacturer", "label": "Manufacturer (including brand owners)", "definition": "Any natural or legal person who manufactures marine equipment or has marine equipment designed or manufactured, and markets that equipment under its name or trademark; an importer or distributor that places equipment on the market or on board under its own name or trademark, or modifies equipment in a way that may affect compliance, is treated as the manufacturer.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 2, point (10), and Art. 14(3)" }, { "id": "other", "label": "Authorised representative (mandatory for manufacturers outside the EU)", "definition": "Any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks; a manufacturer not located in the territory of at least one Member State must appoint one by written mandate, and the mandate cannot cover the manufacturer's responsibility for design and manufacture or the drawing-up of the technical documentation.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 2, point (11), Art. 13(1) and Art. 13(2)" }, { "id": "importer", "label": "Importer", "definition": "Any natural or legal person established within the Union who places marine equipment from a third country on the Union market.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 2, point (12)" }, { "id": "distributor", "label": "Distributor (wholesaler, ship chandler or retailer)", "definition": "Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes marine equipment available on the market.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 2, point (13)" } ], "rules": [ { "categories": [ "equipment-not-subject-to-med-certification" ], "roles": [ "*" ], "size": "any", "result": "out-of-scope", "note": "The wheel mark may be affixed only to equipment whose compliance has been demonstrated under the directive, and the requirements apply to the items listed in the Annex to the implementing regulation; chapter 9 of that Annex lists items that are not subject to MED certification for information only, so such items and unlisted components need no wheel mark, although the ship's own rules and other Union law may still apply to them.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1434 · Art. 1 and Annex, chapter 9; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 9(1) and Art. 9(2)" }, { "categories": [ "non-eu-flag-ship-equipment", "non-convention-ship-equipment" ], "roles": [ "*" ], "size": "any", "result": "out-of-scope", "note": "The directive applies to equipment placed or to be placed on board an EU ship, defined as a ship flying the flag of a Member State and falling within the SOLAS, MARPOL and COLREG conventions; equipment for other ships is outside it, although a non-EU ship transferred to a Member State flag is inspected and its equipment must bear the wheel mark or be accepted as equivalent, and national rules of the flag State may still require approved equipment on ships outside the conventions.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 2, points (2) and (3), Art. 3(1) and Art. 7" }, { "categories": [ "life-saving-appliances", "marine-pollution-prevention-equipment", "fire-protection-equipment", "navigation-equipment", "radio-communication-equipment", "colreg-solas-other-safety-equipment" ], "roles": [ "manufacturer", "other", "importer", "distributor" ], "size": "any", "result": "in-scope", "note": "Equipment listed in the implementing regulation and placed on board an EU ship must meet the requirements and testing standards of the international instruments, proven solely through the Annex II conformity assessment procedures carried out by a notified body, the EU declaration of conformity and the wheel mark; the obligations fall on the manufacturer, the authorised representative, the importer and the distributor and contain no company-size threshold.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 3(1), Art. 4, Art. 9, Art. 12 to Art. 15; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1434 · Art. 1" }, { "categories": [ "pre-2016-approved-equipment" ], "roles": [ "*" ], "size": "any", "result": "depends", "note": "The requirements of Article 4 apply to equipment placed on board on or after 18 September 2016, while Member States must keep equipment already on board in line with the international instruments applicable to it, including new requirements the Commission indicates for existing equipment; the requirements and testing standards in force under Directive 96/98/EC continued only until the first implementing regulation entered into force.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 4(1), Art. 5(2), Art. 35(3) and Art. 40(2)" }, { "categories": [ "exceptional-replacement-equipment" ], "roles": [ "*" ], "size": "any", "result": "depends", "note": "A flag State administration may permit equipment without a wheel mark on board for technical innovation, for testing or evaluation without replacing compliant equipment, or in exceptional circumstances when equipment must be replaced in a port outside the Union or wheel-marked equipment is not available on the market; equipment replaced in a port outside the Union must be accompanied by documentation issued by an IMO Member State party to the relevant conventions and the flag State administration informed at once, while an interim certificate of approval is required only where wheel-marked equipment is shown to be unavailable on the market; in every case the flag State must ensure at the earliest opportunity that the equipment complies.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 30, Art. 31 and Art. 32" }, { "categories": [ "spare-parts-and-replacements" ], "roles": [ "*" ], "size": "any", "result": "depends", "note": "Replacement equipment placed on board an EU ship must meet the requirements of the international instruments applicable at the time it is placed on board, so a replacement of a listed item needs the wheel mark, while parts that are not themselves listed items are not wheel-marked; the placing-on-board dates and any last-placing-on-board dates for superseded standards are set per item in the implementing regulation.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 4(1) and Art. 35(2); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1434 · Annex, notes (c) to (e)" }, { "categories": [ "*" ], "roles": [ "*" ], "size": "any", "result": "depends", "note": "Whether the directive applies turns on whether the equipment is destined for a ship flying an EU Member State flag within the international conventions, whether the item is one for which those conventions require flag State approval and is listed in the implementing regulation, when it is placed on board, and which role the operator holds.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 2, point (2), Art. 3 and Art. 4" } ] }, "obligations": { "manufacturer": [ { "text": "By affixing the wheel mark, take on responsibility that the equipment has been designed and manufactured in accordance with the technical specifications and standards implemented under Article 35(2), currently Implementing Regulation (EU) 2026/1434, and assume the duties of Article 12(2) to (9).", "id": "med-mfr-affixing-wheel-mark", "kind": "evidence", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(1); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1434 · Art. 1" }, { "text": "Draw up the technical documentation and have the applicable conformity assessment carried out through a single notified body of your choice, using the module the implementing regulation allows for the item: EC type-examination (module B) followed by production quality assurance (module D), product quality assurance (module E) or product verification (module F), or EC unit verification (module G) for equipment produced individually or in small quantities.", "id": "med-mfr-draw-technical-documentation", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(2), Art. 15(2) and Annex II, module B, point 3" }, { "text": "Draw up the technical documentation that the applicable conformity assessment module requires for the item of marine equipment.", "id": "med-mfr-compile-technical-documentation", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(2) and Annex II, module B, point 3" }, { "text": "Have the conformity assessment carried out through a single notified body of your choice, using the module the implementing regulation allows: EC type-examination (module B) followed by module D, E or F, or EC unit verification (module G) for equipment produced individually or in small quantities.", "id": "med-mfr-carry-out-conformity-assessment", "kind": "procedure", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(2) and Art. 15(2)" }, { "text": "Once conformity is demonstrated, draw up the EU declaration of conformity following the model in Annex III to Decision No 768/2008/EC with the elements of the relevant modules, keep it up to date, and affix the wheel mark at the end of the production phase, visibly, legibly and indelibly on the product or its data plate and where relevant embedded in its software, followed by the notified body's identification number where that body is involved in production control and the year of affixing.", "id": "med-mfr-draw-declaration-conformity", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "declaration-of-conformity", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(3), Art. 16(2), Art. 9 and Art. 10" }, { "text": "Once conformity is demonstrated, draw up the EU declaration of conformity following the model in Annex III to Decision No 768/2008/EC with the elements of the relevant modules, and keep it up to date.", "id": "med-mfr-draw-eu-declaration", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "declaration-of-conformity", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(3) and Art. 16(2)" }, { "text": "Affix the wheel mark at the end of the production phase, visibly, legibly and indelibly on the product or its data plate and, where relevant, embedded in its software, followed by the notified body's identification number where that body is involved in production control and the year of affixing.", "id": "med-mfr-affix-wheel-mark", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "ce-marking", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 9 and Art. 10" }, { "text": "Provide a copy of the EU declaration of conformity to the ship when the equipment is placed on board, translated into the languages the flag Member State requires and at least a language commonly used in the maritime transport sector, to be kept on board until the equipment is removed, and provide a copy to the notified body that carried out the assessment.", "id": "med-mfr-provide-copy-declaration", "kind": "evidence", "level": "lot", "timing": "per-lot", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 16(4) and Art. 16(5)" }, { "text": "Keep the technical documentation and the EU declaration of conformity for at least 10 years after the wheel mark has been affixed and in no case for a period shorter than the expected life of the equipment.", "id": "med-mfr-keep-technical-documentation", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(4)" }, { "text": "Keep series production in conformity, taking account of changes in the equipment's design or characteristics and of changes in the international instruments on which conformity was declared, and have a new conformity assessment carried out when Annex II requires it; inform the notified body holding the type-examination file of any modification that may affect conformity or the validity of the certificate.", "id": "med-mfr-keep-series-production", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(5) and Annex II, module B, point 7" }, { "text": "Mark the product with a type, batch or serial number or other identifier and with your name, registered trade name or trade mark and a single contact address, or where the size or nature of the product does not allow it, on the packaging or in an accompanying document, and supply instructions and all information needed for safe installation on board and safe use, including any limitations of use, together with any other documentation the international instruments or testing standards require.", "id": "med-mfr-mark-product-type", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(6), Art. 12(7) and Art. 12(8)" }, { "text": "Mark the product with a type, batch or serial number or other identifier and with your name, registered trade name or trade mark and a single contact address or, where the product does not allow it, put them on the packaging or in an accompanying document.", "id": "med-mfr-mark-type-name-address", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(6) and Art. 12(7)" }, { "text": "Supply instructions and all information needed for safe installation on board and safe use, including any limitations of use, together with any other documentation the international instruments or testing standards require.", "id": "med-mfr-supply-installation-instructions", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(8)" }, { "text": "If you consider or have reason to believe that wheel-marked equipment does not conform to the applicable requirements and testing standards, immediately bring it into conformity, withdraw or recall it, and where it presents a risk inform the competent national authorities with details of the non-compliance and the corrective measures; on reasoned request provide all conformity information and documentation in a language the authority accepts, give access to your premises for market surveillance, provide samples at your own cost where reasonable and cooperate on risk-elimination measures.", "id": "med-mfr-immediately-bring-conformity", "kind": "submission", "level": "product", "timing": "on-event", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(9), Art. 12(10) and Art. 25(4)" }, { "text": "If you consider that wheel-marked equipment does not conform to the applicable requirements and testing standards, immediately bring it into conformity, withdraw or recall it, and where it presents a risk inform the competent national authorities with details of the non-compliance and the corrective measures.", "id": "med-mfr-take-corrective-measures", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(9)" }, { "text": "On reasoned request, provide all conformity information and documentation in a language the authority accepts, give access to your premises for market surveillance, provide samples at your own cost where reasonable and cooperate on measures to eliminate the risks.", "id": "med-mfr-provide-information-request", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(10) and Art. 25(4)" } ], "other": [ { "text": "If the manufacturer is not located in the territory of at least one Member State, be appointed by a written mandate that names you and the address at which you can be contacted; the appointment is mandatory for such manufacturers.", "id": "med-oth-appointed-written-mandate", "kind": "evidence", "level": "company", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 13(1)" }, { "text": "Perform the tasks specified in the mandate, which must at least let you keep the EU declaration of conformity and the technical documentation at the disposal of the national surveillance authorities for at least 10 years after the wheel mark has been affixed and never shorter than the expected life of the equipment, provide conformity information and documentation on reasoned request, and cooperate with the authorities on risk-elimination measures.", "id": "med-oth-perform-tasks-specified", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 13(3)" }, { "text": "Keep the EU declaration of conformity and the technical documentation at the disposal of the national surveillance authorities for at least 10 years after the wheel mark has been affixed, and never for less than the expected life of the equipment.", "id": "med-oth-keep-documentation-years", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 13(3)(a)" }, { "text": "On reasoned request, provide the authority with the information and documentation demonstrating conformity, and cooperate with it on measures to eliminate the risks of the equipment covered by your mandate.", "id": "med-oth-provide-information-request", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 13(3)(b) and Art. 13(3)(c)" }, { "text": "Do not take over the manufacturer's responsibility under Article 12(1) for design and manufacture to the implemented specifications and standards, nor the drawing-up of the technical documentation; those cannot form part of the mandate.", "id": "med-oth-take-manufacturers-responsibility", "kind": "status", "level": "company", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 13(2)" }, { "text": "Where the mandate specifies it, lodge the application for EC type-examination or quality-system assessment with the notified body, inform the notified body of modifications to the approved type, keep the certificates and documentation, and affix the wheel mark and draw up the declaration on the manufacturer's behalf and under its responsibility; under module F you may not take over the manufacturing and lot-homogeneity duties.", "id": "med-oth-lodge-application-type-examination", "kind": "submission", "level": "product", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Annex II, module B, point 10, module D, point 8, module E, point 8, module F, point 8, and module G, point 6" }, { "text": "Where the mandate specifies it, lodge the application for EC type-examination or quality-system assessment with the notified body, and inform it of modifications to the approved type; under module F you may not take over the manufacturing and lot-homogeneity duties.", "id": "med-oth-lodge-application-notified-body", "kind": "submission", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Annex II, module B, point 10, module D, point 8, module E, point 8, module F, point 8, and module G, point 6" }, { "text": "Where the mandate specifies it, affix the wheel mark on the manufacturer's behalf and under its responsibility.", "id": "med-oth-affix-wheel-mark", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "ce-marking", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Annex II, module D, point 8, module E, point 8, module F, point 8, and module G, point 6" }, { "text": "Where the mandate specifies it, draw up the EU declaration of conformity on the manufacturer's behalf and under its responsibility, and keep the certificates and documentation with it.", "id": "med-oth-draw-eu-declaration", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "declaration-of-conformity", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Annex II, module B, point 10, module D, point 8, module E, point 8, module F, point 8, and module G, point 6" }, { "text": "On request, identify to the market surveillance authorities every economic operator that supplied you with a product and every operator you supplied, for at least 10 years after the wheel mark was affixed and never shorter than the expected life of the equipment.", "id": "med-oth-identify-market-surveillance", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 14(4)" } ], "importer": [ { "text": "Indicate your name, registered trade name or registered trade mark and the address at which you can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product, or both.", "id": "med-imp-indicate-name-registered", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 14(1)" }, { "text": "On reasoned request from a competent authority, provide all the information and documentation necessary to demonstrate the conformity of the product in a language the authority can easily understand or accepts, and cooperate with that authority on any action taken to eliminate the risks posed by products you placed on the market.", "id": "med-imp-provide-information-documentation", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 14(2)" }, { "text": "If you place equipment on the market or on board an EU ship under your own name or trademark, or modify equipment already placed on the market in a way that may affect compliance with the applicable requirements, you are considered the manufacturer and carry all the obligations of Article 12.", "id": "med-imp-modify-equipment-already", "kind": "status", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 14(3)" }, { "text": "On request, identify to the market surveillance authorities every economic operator that supplied you with a product and every operator you supplied, for at least 10 years after the wheel mark was affixed and never shorter than the expected life of the equipment.", "id": "med-imp-identify-market-surveillance", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 14(4)" }, { "text": "Cooperate with the market surveillance authorities in their evaluation of equipment believed to present a risk to maritime safety, health or the environment, take the corrective action they require within the period they prescribe, and ensure it covers all the products concerned that you made available throughout the Union or delivered to be placed on board EU ships.", "id": "med-imp-cooperate-market-surveillance", "kind": "evidence", "level": "product", "timing": "on-event", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 26(1), Art. 26(3) and Art. 28(2)" } ], "distributor": [ { "text": "On reasoned request from a competent authority, provide all the information and documentation necessary to demonstrate the conformity of the product in a language the authority can easily understand or accepts, and cooperate with that authority on any action taken to eliminate the risks posed by products you placed on the market.", "id": "med-dist-provide-information-documentation", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 14(2)" }, { "text": "If you make equipment available under your own name or trademark, or modify equipment already placed on the market in a way that may affect compliance with the applicable requirements, you are considered the manufacturer and carry all the obligations of Article 12.", "id": "med-dist-modify-equipment-already", "kind": "status", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 14(3)" }, { "text": "On request, identify to the market surveillance authorities every economic operator that supplied you with a product and every operator you supplied, for at least 10 years after the wheel mark was affixed and never shorter than the expected life of the equipment.", "id": "med-dist-identify-market-surveillance", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 14(4)" }, { "text": "Cooperate with the market surveillance authorities in their evaluation of equipment believed to present a risk, take the corrective action they require within the period they prescribe, and put an end to any formal non-compliance they find, such as a missing or wrongly affixed wheel mark, a missing or incorrect EU declaration of conformity, incomplete technical documentation or a declaration not sent to the ship.", "id": "med-dist-cooperate-market-surveillance", "kind": "evidence", "level": "product", "timing": "on-event", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 26(1), Art. 26(3) and Art. 29(1)" } ] }, "requirements": [ { "id": "med-mfr-affixing-wheel-mark", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "text": "By affixing the wheel mark, take on responsibility that the equipment has been designed and manufactured in accordance with the technical specifications and standards implemented under Article 35(2), currently Implementing Regulation (EU) 2026/1434, and assume the duties of Article 12(2) to (9).", "article": "Art. 12(1); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1434 · Art. 1", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-draw-technical-documentation", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "retired": "2026-09-24", "text": "Draw up the technical documentation and have the applicable conformity assessment carried out through a single notified body of your choice, using the module the implementing regulation allows for the item: EC type-examination (module B) followed by production quality assurance (module D), product quality assurance (module E) or product verification (module F), or EC unit verification (module G) for equipment produced individually or in small quantities.", "article": "Art. 12(2), Art. 15(2) and Annex II, module B, point 3", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-compile-technical-documentation", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "text": "Draw up the technical documentation that the applicable conformity assessment module requires for the item of marine equipment.", "article": "Art. 12(2) and Annex II, module B, point 3", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-carry-out-conformity-assessment", "role": "manufacturer", "kind": "procedure", "level": "product", "timing": "before-market", "text": "Have the conformity assessment carried out through a single notified body of your choice, using the module the implementing regulation allows: EC type-examination (module B) followed by module D, E or F, or EC unit verification (module G) for equipment produced individually or in small quantities.", "article": "Art. 12(2) and Art. 15(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-draw-declaration-conformity", "role": "manufacturer", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "declaration-of-conformity", "retired": "2026-09-24", "text": "Once conformity is demonstrated, draw up the EU declaration of conformity following the model in Annex III to Decision No 768/2008/EC with the elements of the relevant modules, keep it up to date, and affix the wheel mark at the end of the production phase, visibly, legibly and indelibly on the product or its data plate and where relevant embedded in its software, followed by the notified body's identification number where that body is involved in production control and the year of affixing.", "article": "Art. 12(3), Art. 16(2), Art. 9 and Art. 10", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-draw-eu-declaration", "role": "manufacturer", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "declaration-of-conformity", "text": "Once conformity is demonstrated, draw up the EU declaration of conformity following the model in Annex III to Decision No 768/2008/EC with the elements of the relevant modules, and keep it up to date.", "article": "Art. 12(3) and Art. 16(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-affix-wheel-mark", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "ce-marking", "text": "Affix the wheel mark at the end of the production phase, visibly, legibly and indelibly on the product or its data plate and, where relevant, embedded in its software, followed by the notified body's identification number where that body is involved in production control and the year of affixing.", "article": "Art. 9 and Art. 10", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-provide-copy-declaration", "role": "manufacturer", "kind": "evidence", "level": "lot", "timing": "per-lot", "text": "Provide a copy of the EU declaration of conformity to the ship when the equipment is placed on board, translated into the languages the flag Member State requires and at least a language commonly used in the maritime transport sector, to be kept on board until the equipment is removed, and provide a copy to the notified body that carried out the assessment.", "article": "Art. 16(4) and Art. 16(5)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-keep-technical-documentation", "role": "manufacturer", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Keep the technical documentation and the EU declaration of conformity for at least 10 years after the wheel mark has been affixed and in no case for a period shorter than the expected life of the equipment.", "article": "Art. 12(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-keep-series-production", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Keep series production in conformity, taking account of changes in the equipment's design or characteristics and of changes in the international instruments on which conformity was declared, and have a new conformity assessment carried out when Annex II requires it; inform the notified body holding the type-examination file of any modification that may affect conformity or the validity of the certificate.", "article": "Art. 12(5) and Annex II, module B, point 7", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-mark-product-type", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "retired": "2026-09-24", "text": "Mark the product with a type, batch or serial number or other identifier and with your name, registered trade name or trade mark and a single contact address, or where the size or nature of the product does not allow it, on the packaging or in an accompanying document, and supply instructions and all information needed for safe installation on board and safe use, including any limitations of use, together with any other documentation the international instruments or testing standards require.", "article": "Art. 12(6), Art. 12(7) and Art. 12(8)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-mark-type-name-address", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "text": "Mark the product with a type, batch or serial number or other identifier and with your name, registered trade name or trade mark and a single contact address or, where the product does not allow it, put them on the packaging or in an accompanying document.", "article": "Art. 12(6) and Art. 12(7)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-supply-installation-instructions", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "text": "Supply instructions and all information needed for safe installation on board and safe use, including any limitations of use, together with any other documentation the international instruments or testing standards require.", "article": "Art. 12(8)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-immediately-bring-conformity", "role": "manufacturer", "kind": "submission", "level": "product", "timing": "on-event", "retired": "2026-09-24", "text": "If you consider or have reason to believe that wheel-marked equipment does not conform to the applicable requirements and testing standards, immediately bring it into conformity, withdraw or recall it, and where it presents a risk inform the competent national authorities with details of the non-compliance and the corrective measures; on reasoned request provide all conformity information and documentation in a language the authority accepts, give access to your premises for market surveillance, provide samples at your own cost where reasonable and cooperate on risk-elimination measures.", "article": "Art. 12(9), Art. 12(10) and Art. 25(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-take-corrective-measures", "role": "manufacturer", "kind": "submission", "level": "product", "timing": "on-event", "text": "If you consider that wheel-marked equipment does not conform to the applicable requirements and testing standards, immediately bring it into conformity, withdraw or recall it, and where it presents a risk inform the competent national authorities with details of the non-compliance and the corrective measures.", "article": "Art. 12(9)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-mfr-provide-information-request", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On reasoned request, provide all conformity information and documentation in a language the authority accepts, give access to your premises for market surveillance, provide samples at your own cost where reasonable and cooperate on measures to eliminate the risks.", "article": "Art. 12(10) and Art. 25(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-oth-appointed-written-mandate", "role": "other", "kind": "evidence", "level": "company", "timing": "before-market", "text": "If the manufacturer is not located in the territory of at least one Member State, be appointed by a written mandate that names you and the address at which you can be contacted; the appointment is mandatory for such manufacturers.", "article": "Art. 13(1)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-oth-perform-tasks-specified", "role": "other", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "retired": "2026-09-24", "text": "Perform the tasks specified in the mandate, which must at least let you keep the EU declaration of conformity and the technical documentation at the disposal of the national surveillance authorities for at least 10 years after the wheel mark has been affixed and never shorter than the expected life of the equipment, provide conformity information and documentation on reasoned request, and cooperate with the authorities on risk-elimination measures.", "article": "Art. 13(3)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-oth-keep-documentation-years", "role": "other", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Keep the EU declaration of conformity and the technical documentation at the disposal of the national surveillance authorities for at least 10 years after the wheel mark has been affixed, and never for less than the expected life of the equipment.", "article": "Art. 13(3)(a)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-oth-provide-information-request", "role": "other", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On reasoned request, provide the authority with the information and documentation demonstrating conformity, and cooperate with it on measures to eliminate the risks of the equipment covered by your mandate.", "article": "Art. 13(3)(b) and Art. 13(3)(c)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-oth-take-manufacturers-responsibility", "role": "other", "kind": "status", "level": "company", "timing": "before-market", "text": "Do not take over the manufacturer's responsibility under Article 12(1) for design and manufacture to the implemented specifications and standards, nor the drawing-up of the technical documentation; those cannot form part of the mandate.", "article": "Art. 13(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-oth-lodge-application-type-examination", "role": "other", "kind": "submission", "level": "product", "timing": "before-market", "retired": "2026-09-24", "text": "Where the mandate specifies it, lodge the application for EC type-examination or quality-system assessment with the notified body, inform the notified body of modifications to the approved type, keep the certificates and documentation, and affix the wheel mark and draw up the declaration on the manufacturer's behalf and under its responsibility; under module F you may not take over the manufacturing and lot-homogeneity duties.", "article": "Annex II, module B, point 10, module D, point 8, module E, point 8, module F, point 8, and module G, point 6", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-oth-lodge-application-notified-body", "role": "other", "kind": "submission", "level": "product", "timing": "before-market", "text": "Where the mandate specifies it, lodge the application for EC type-examination or quality-system assessment with the notified body, and inform it of modifications to the approved type; under module F you may not take over the manufacturing and lot-homogeneity duties.", "article": "Annex II, module B, point 10, module D, point 8, module E, point 8, module F, point 8, and module G, point 6", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-oth-affix-wheel-mark", "role": "other", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "ce-marking", "text": "Where the mandate specifies it, affix the wheel mark on the manufacturer's behalf and under its responsibility.", "article": "Annex II, module D, point 8, module E, point 8, module F, point 8, and module G, point 6", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-oth-draw-eu-declaration", "role": "other", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "declaration-of-conformity", "text": "Where the mandate specifies it, draw up the EU declaration of conformity on the manufacturer's behalf and under its responsibility, and keep the certificates and documentation with it.", "article": "Annex II, module B, point 10, module D, point 8, module E, point 8, module F, point 8, and module G, point 6", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-oth-identify-market-surveillance", "role": "other", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "On request, identify to the market surveillance authorities every economic operator that supplied you with a product and every operator you supplied, for at least 10 years after the wheel mark was affixed and never shorter than the expected life of the equipment.", "article": "Art. 14(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-imp-indicate-name-registered", "role": "importer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "text": "Indicate your name, registered trade name or registered trade mark and the address at which you can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product, or both.", "article": "Art. 14(1)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-imp-provide-information-documentation", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On reasoned request from a competent authority, provide all the information and documentation necessary to demonstrate the conformity of the product in a language the authority can easily understand or accepts, and cooperate with that authority on any action taken to eliminate the risks posed by products you placed on the market.", "article": "Art. 14(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-imp-modify-equipment-already", "role": "importer", "kind": "status", "level": "product", "timing": "before-market", "text": "If you place equipment on the market or on board an EU ship under your own name or trademark, or modify equipment already placed on the market in a way that may affect compliance with the applicable requirements, you are considered the manufacturer and carry all the obligations of Article 12.", "article": "Art. 14(3)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-imp-identify-market-surveillance", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "On request, identify to the market surveillance authorities every economic operator that supplied you with a product and every operator you supplied, for at least 10 years after the wheel mark was affixed and never shorter than the expected life of the equipment.", "article": "Art. 14(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-imp-cooperate-market-surveillance", "role": "importer", "kind": "evidence", "level": "product", "timing": "on-event", "sharedKey": "authority-cooperation", "text": "Cooperate with the market surveillance authorities in their evaluation of equipment believed to present a risk to maritime safety, health or the environment, take the corrective action they require within the period they prescribe, and ensure it covers all the products concerned that you made available throughout the Union or delivered to be placed on board EU ships.", "article": "Art. 26(1), Art. 26(3) and Art. 28(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-dist-provide-information-documentation", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On reasoned request from a competent authority, provide all the information and documentation necessary to demonstrate the conformity of the product in a language the authority can easily understand or accepts, and cooperate with that authority on any action taken to eliminate the risks posed by products you placed on the market.", "article": "Art. 14(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-dist-modify-equipment-already", "role": "distributor", "kind": "status", "level": "product", "timing": "before-market", "text": "If you make equipment available under your own name or trademark, or modify equipment already placed on the market in a way that may affect compliance with the applicable requirements, you are considered the manufacturer and carry all the obligations of Article 12.", "article": "Art. 14(3)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-dist-identify-market-surveillance", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "On request, identify to the market surveillance authorities every economic operator that supplied you with a product and every operator you supplied, for at least 10 years after the wheel mark was affixed and never shorter than the expected life of the equipment.", "article": "Art. 14(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "id": "med-dist-cooperate-market-surveillance", "role": "distributor", "kind": "evidence", "level": "product", "timing": "on-event", "sharedKey": "authority-cooperation", "text": "Cooperate with the market surveillance authorities in their evaluation of equipment believed to present a risk, take the corrective action they require within the period they prescribe, and put an end to any formal non-compliance they find, such as a missing or wrongly affixed wheel mark, a missing or incorrect EU declaration of conformity, incomplete technical documentation or a declaration not sent to the ship.", "article": "Art. 26(1), Art. 26(3) and Art. 29(1)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" } ], "requirementsHash": "8109dafaa4222cc5", "penalties": { "text": "The directive contains no penalties article of its own; it is listed in Annex II to Regulation (EU) 2019/1020 among the Union harmonisation legislation without provisions on penalties, so Member States must lay down effective, proportionate and dissuasive penalties for infringements by economic operators under Article 41 of that regulation. Market surveillance authorities evaluate equipment believed to present a risk to maritime safety, health or the environment, require corrective action, withdrawal or recall within a period commensurate with the risk, inform the notified body, and if the operator fails to act prohibit or restrict the making available or placing on board of the equipment, withdraw or recall it and notify the Commission and the other Member States; compliant equipment that still presents a risk can be treated the same way, and formal non-compliance, such as a wheel mark affixed in breach of Articles 9 or 10, a missing wheel mark, a missing or incorrect EU declaration of conformity, unavailable or incomplete technical documentation or a declaration not sent to the ship, must be ended and otherwise leads to restriction, prohibition, withdrawal or recall. Notified bodies must refuse a certificate where the manufacturer's obligations are not met and suspend, restrict or withdraw a certificate where a product no longer complies and corrective measures are not taken. In Denmark, executive order nr. 422 of 17 May 2016 on equipment in ships, issued by Søfartsstyrelsen under lov om sikkerhed til søs, punishes breaches with a fine or imprisonment of up to one year, rising to two years where the breach harmed or endangered life or health, followed an earlier prohibition or order for the same or a similar matter, or gained or aimed at an economic advantage, with companies liable under Chapter 5 of the Danish Criminal Code; under lov om sikkerhed til søs, Søfartsstyrelsen can order marketing stopped and products recalled, use the control powers of the product and market surveillance act, detain a ship that lacks prescribed equipment or whose equipment is defective, and failure to comply with its orders is punished with a fine or imprisonment of up to one year.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 23(2), Art. 23(3), Art. 26, Art. 28 and Art. 29; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R1020 · Art. 41 and Annex II; https://www.retsinformation.dk/eli/lta/2016/422 · § 2; https://www.retsinformation.dk/eli/lta/2022/221 · § 4, stk. 4 and 5, § 14, stk. 2, § 18 and § 28" }, "checklist": [ "Confirm the equipment is destined for a ship flying an EU Member State flag within SOLAS, MARPOL or COLREG and find the item in the Annex to Implementing Regulation (EU) 2026/1434 with its requirements, testing standards, allowed modules and placing-on-the-market and placing-on-board dates (Articles 3 and 4; Implementing Regulation (EU) 2026/1434, Article 1 and Annex).", "Decide your role for each product, remembering that selling under your own name or trademark or modifying the equipment makes you the manufacturer, and appoint an EU authorised representative by written mandate if the manufacturer is not located in a Member State (Articles 13(1) and 14(3)).", "Compile the technical documentation with the risk analysis, drawings, the list of applicable requirements and testing standards, the solutions adopted, calculations and test reports (Annex II, module B, point 3, or module G, point 2).", "Choose a single notified body, apply for EC type-examination (module B) and the production module the implementing regulation allows (D, E or F), or for EC unit verification (module G) for individual or small-quantity production (Article 15(2) and Annex II).", "Draw up the EU declaration of conformity on the Decision No 768/2008/EC model with the elements of the modules used, keep it up to date and send a copy to the notified body (Article 16(2) and 16(5)).", "Affix the wheel mark at the end of production on the product or its data plate, embedded in software where relevant, followed by the notified body number and the year, or use an RFID or data-matrix electronic tag for items listed in Delegated Regulation (EU) 2018/414 per the criteria of Implementing Regulation (EU) 2018/608 (Articles 9 to 11).", "Mark the identifier, your name and single contact address and, for importers, the importer's name and address, and supply installation and use instructions with any limitations of use (Articles 12(6) to 12(8) and 14(1)).", "Deliver a translated copy of the EU declaration of conformity with the equipment to the ship, to be kept on board until the equipment is removed (Article 16(4)).", "Keep the technical documentation, declaration and certificates for at least 10 years after affixing the wheel mark and never shorter than the equipment's expected life, and keep supplier and customer traceability for the same period (Articles 12(4), 13(3) and 14(4)).", "Set up the corrective-action and authority-notification procedure and track the annual implementing regulation and the placing-on-board dates so series production stays in conformity (Articles 12(5), 12(9) and 35(2))." ], "faq": [ { "q": "When did the Marine Equipment Directive 2014/90/EU start to apply?", "a": "The directive was adopted on 23 July 2014, published in OJ L 257 of 28 August 2014 and entered into force on 17 September 2014. Member States had to adopt and publish their transposing laws by 18 September 2016 and apply them from that date, when Directive 96/98/EC was repealed; the requirements of Article 4 apply to equipment placed on board an EU ship on or after 18 September 2016.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 4(1), Art. 39, Art. 40 and Art. 41" }, { "q": "Which equipment needs the wheel mark?", "a": "Equipment placed or to be placed on board an EU ship, that is a ship flying a Member State flag within the SOLAS, MARPOL or COLREG conventions, for which those international instruments require the flag State administration's approval. The concrete items, with their requirements, testing standards and allowed conformity assessment modules, are listed in the Annex to the Commission's implementing regulation, currently Implementing Regulation (EU) 2026/1434, in chapters for life-saving appliances, marine pollution prevention, fire protection, navigation, radio-communication, COLREG equipment, other safety equipment and SOLAS Chapter II-1 equipment; a ninth chapter lists items not subject to MED certification for information only.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 2, point (2), Art. 3(1) and Art. 35(2); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1434 · Art. 1 and Annex" }, { "q": "Is the wheel mark the same as the CE marking?", "a": "No. Marine equipment within the directive carries the wheel mark in the form set out in Annex I, not the CE marking, and the wheel mark may not be affixed to any other product. It is subject to the general principles of Article 30(1) and (3) to (6) of Regulation (EC) No 765/2008 with every reference to the CE marking read as the wheel mark, is affixed at the end of the production phase, visibly, legibly and indelibly, and is followed by the identification number of the notified body involved in production control and the year of affixing. Equipment within the directive is subject only to the directive for the purpose of uniform application of the international instruments, even where it would also fall under other Union law.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 3(2), Art. 9, Art. 10 and Annex I" }, { "q": "Do I need a notified body under the MED?", "a": "Yes. Compliance may be demonstrated solely through the Annex II procedures carried out through a notified body: EC type-examination (module B) combined with production quality assurance (module D), product quality assurance (module E) or product verification (module F), or EC unit verification (module G) where equipment is produced individually or in small quantities and not in series. The implementing regulation states per item which of those options are available, and the manufacturer lodges the application with a single notified body of its choice.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 4(2), Art. 15 and Annex II, module B, point 3" }, { "q": "Can an electronic tag replace the wheel mark?", "a": "For the items listed in Delegated Regulation (EU) 2018/414, manufacturers may use an appropriate and reliable electronic tag instead of, or in addition to, the wheel mark, with Articles 9 and 10 applying mutatis mutandis. Implementing Regulation (EU) 2018/608 sets the technical criteria: permanently affixed RFID tags or optically readable data-matrix codes, which must display the symbol in its Annex when they replace the wheel mark. Under Article 11, the wheel mark may be supplemented by a tag within three years and replaced five years after the adoption of those criteria.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 11; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R0414 · Art. 1; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R0608 · Art. 1 to Art. 3" }, { "q": "What must be on board the ship for wheel-marked equipment?", "a": "When the equipment is placed on board an EU ship, a copy of the EU declaration of conformity covering it must be provided to the ship and kept on board until the equipment is removed. The manufacturer translates it into the language or languages the flag Member State requires, including at least a language commonly used in the maritime transport sector. A declaration that has not been sent to the ship is formal non-compliance that the Member State must require the operator to end.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 16(4) and Art. 29(1)(f)" }, { "q": "What happens when equipment must be replaced in a port outside the EU and no wheel-marked equipment is available?", "a": "In exceptional circumstances justified to the flag State administration, when replacement in a port outside the Union with wheel-marked equipment is not practicable in terms of reasonable time, delay and cost, other equipment may be placed on board if it is accompanied by documentation from an IMO Member State party to the relevant conventions certifying compliance with the IMO requirements; the flag State must be informed at once and must ensure at the earliest opportunity that the equipment complies. Where wheel-marked equipment is shown to be unavailable on the market, the flag Member State may authorise other equipment under an interim certificate of approval that names the equipment it replaces, the circumstances, the requirements applied and the testing standards, and must inform the Commission forthwith.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 32" }, { "q": "How long must I keep the documentation and who must appoint an authorised representative?", "a": "Manufacturers keep the technical documentation and EU declaration of conformity, and authorised representatives keep them at the disposal of the surveillance authorities, for at least 10 years after the wheel mark has been affixed and in no case for a period shorter than the expected life of the equipment; the same period applies to identifying suppliers and customers. A manufacturer not located in the territory of at least one Member State must appoint an authorised representative for the Union by written mandate, which cannot cover the manufacturer's design and manufacturing responsibility or the technical documentation.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 12(4), Art. 13 and Art. 14(4)" } ], "changelog": [ { "date": "2026-09-12", "kind": "guidance", "title": "Guide rewritten from the consolidated text of 2 August 2026", "summary": "The body now follows the consolidated directive article by article: the scope is tied to EU ships within the SOLAS, MARPOL and COLREG conventions and the implementing regulation's item list, the conformity routes are mapped to the Annex II modules B plus D, E or F and module G, the authorised representative is shown as mandatory for manufacturers outside the EU, the importer and distributor duties are limited to what Article 14 actually requires (the earlier text wrongly gave importers and distributors a duty to verify the conformity assessment and wheel mark), the electronic tag is documented from Delegated Regulation (EU) 2018/414 and Implementing Regulation (EU) 2018/608, the exemptions in Articles 30 to 32 are distinguished, and the Danish enforcement basis is sourced from executive order nr. 422 of 2016 and lov om sikkerhed til søs.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0090-20260802 · Art. 2 to Art. 4, Art. 9 to Art. 16, Art. 25 to Art. 32 and Annex II" }, { "date": "2026-08-31", "kind": "applies", "title": "Implementing Regulation (EU) 2026/1434 replaces the 2025 list of requirements and testing standards", "summary": "The 2026 implementing regulation, adopted on 30 June 2026 and published on 22 July 2026, entered into force on the fortieth day after publication and repealed Implementing Regulation (EU) 2025/1533; its Annex lists each item of marine equipment with the applicable international instruments, testing standards, conformity assessment modules and first placing-on-the-market and last placing-on-board dates, and Article 3 keeps national type-approvals valid until 4 September 2027 for items first inserted in 2024 and until 23 September 2028 for items first inserted in 2025.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1434 · Art. 1 to Art. 4" }, { "date": "2026-08-02", "kind": "applies", "title": "Article 8(5) on AI safety components applies", "summary": "The paragraph added by the Artificial Intelligence Act applies: for AI systems that are safety components within the meaning of Regulation (EU) 2024/1689, the Commission takes into account the requirements of Chapter III, Section 2 of that regulation when pursuing international standards and when adopting harmonised technical specifications and testing standards under Article 8.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689 · Art. 113; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0090-20260802 · Art. 8(5)" }, { "date": "2024-08-01", "kind": "amendment", "title": "Regulation (EU) 2024/1689 (Artificial Intelligence Act) in force", "summary": "The AI Act of 13 June 2024, published on 12 July 2024, amends Article 8 of the directive through its Article 105 by adding paragraph 5 on AI systems that are safety components of marine equipment, and lists the directive in Section B of its Annex I; the amendment applies from 2 August 2026.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689 · Art. 105, Art. 113 and Annex I, Section B, point 16" }, { "date": "2021-08-11", "kind": "amendment", "title": "Delegated Directive (EU) 2021/1206 in force: EN ISO/IEC 17025:2017 for testing laboratories", "summary": "The Commission's delegated directive of 30 April 2021, published on 22 July 2021, replaced the reference to EN ISO/IEC 17025:2005 in point 19 of Annex III with EN ISO/IEC 17025:2017 after ISO withdrew the 2005 version; Member States had to transpose it by 31 January 2022, and Denmark did so with executive order nr. 251 of 21 February 2022 in force from 28 February 2022.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021L1206 · Art. 1 to Art. 3; https://www.retsinformation.dk/eli/lta/2022/251 · § 1 and § 2" }, { "date": "2018-05-10", "kind": "applies", "title": "Electronic tags: technical criteria and eligible items in place", "summary": "Implementing Regulation (EU) 2018/608 of 19 April 2018 laid down the technical criteria for RFID and data-matrix electronic tags that may supplement or replace the wheel mark, entering into force on 10 May 2018, after Delegated Regulation (EU) 2018/414 of 9 January 2018, in force on 8 April 2018, identified the items of marine equipment that can benefit from electronic tagging.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R0608 · Art. 1 to Art. 4; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R0414 · Art. 1 and Art. 2" }, { "date": "2016-09-18", "kind": "applies", "title": "Directive 2014/90/EU applies; Directive 96/98/EC repealed", "summary": "Member States apply their transposing measures from 18 September 2016, Directive 96/98/EC is repealed with effect from the same date and references to it are read as references to Directive 2014/90/EU; the requirements and testing standards in force under the old directive continued to apply until the first implementing regulation under Article 35(2) entered into force. In Denmark, executive order nr. 422 of 17 May 2016 on equipment in ships entered into force on this date.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 39 and Art. 40; https://www.retsinformation.dk/eli/lta/2016/422 · § 4" }, { "date": "2014-09-17", "kind": "in-force", "title": "Directive 2014/90/EU enters into force", "summary": "Adopted on 23 July 2014 to replace Directive 96/98/EC and published in OJ L 257 on 28 August 2014, the directive entered into force on the twentieth day after publication; Member States had until 18 September 2016 to transpose it.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090 · Art. 39(1) and Art. 41" } ], "sources": [ { "label": "Directive 2014/90/EU on marine equipment, consolidated text of 2 August 2026 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0090-20260802" }, { "label": "Directive 2014/90/EU as published in OJ L 257, 28 August 2014 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0090" }, { "label": "Document information, dates and relationships for CELEX 32014L0090 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32014L0090" }, { "label": "Commission Delegated Directive (EU) 2021/1206 amending Annex III as regards the standard for testing laboratories (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021L1206" }, { "label": "Regulation (EU) 2024/1689, the Artificial Intelligence Act, Article 105 amending Directive 2014/90/EU (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689" }, { "label": "Commission Implementing Regulation (EU) 2026/1434 on design, construction and performance requirements and testing standards for marine equipment (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1434" }, { "label": "Commission Delegated Regulation (EU) 2018/414 identifying the items of marine equipment which can benefit from electronic tagging (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R0414" }, { "label": "Commission Implementing Regulation (EU) 2018/608 laying down technical criteria for electronic tags for marine equipment (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R0608" }, { "label": "Commission Delegated Regulation (EU) 2024/1295 on harmonised technical specifications and testing standards for fire hoses (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1295" }, { "label": "Regulation (EU) 2019/1020 on market surveillance and compliance of products, Article 41 and Annexes I and II (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R1020" }, { "label": "EU actions on safety and environment protection, section on marine equipment (European Commission, DG MOVE)", "url": "https://transport.ec.europa.eu/transport-modes/maritime/safety-and-environment/eu-actions-safety-and-environment-protection_en" }, { "label": "Marine Equipment Directive, MarED and the MED Portal of approved products (European Maritime Safety Agency)", "url": "https://www.emsa.europa.eu/med-directive-mared.html" }, { "label": "Bekendtgørelse om udstyr i skibe, BEK nr. 422 af 17. maj 2016, the Danish implementation of the directive (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2016/422" }, { "label": "Bekendtgørelse om ændring af bekendtgørelse om udstyr i skibe, BEK nr. 251 af 21. februar 2022, transposing Delegated Directive (EU) 2021/1206 (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2022/251" }, { "label": "Bekendtgørelse af lov om sikkerhed til søs, LBK nr. 221 af 11. februar 2022 (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2022/221" } ], "reviewer": { "name": "Conphora compliance team", "role": "Compliance editors, Conphora" }, "reviewedAt": "2026-09-24", "nextReview": "2027-03-12", "links": { "tools": [], "courses": [], "related": { "en": "/regulations/med/", "dk": "/dk/eu-regulativer/med/" } } }