{
  "type": "problem",
  "slug": "medical-or-wellness",
  "lang": "en",
  "url": "https://www.conphora.com/solutions/problem/medical-or-wellness/",
  "markdown": "https://www.conphora.com/solutions/problem/medical-or-wellness.md",
  "title": "We are unsure whether our product is a medical device",
  "description": "When a wellness or health product becomes a medical device under the MDR: intended purpose, medical purposes, Annex XVI products, claims and what follows.",
  "answer": "Under Regulation (EU) 2017/745, a product is a medical device when the manufacturer intends it for a medical purpose, such as diagnosis, prevention, monitoring or treatment of disease or injury. The intended purpose is read from the label, instructions, promotional and sales materials. Some products without a medical purpose, listed in Annex XVI, are covered too. Decide the intended purpose first, then keep every claim consistent with it.",
  "theme": {
    "id": "placing-on-market",
    "label": "Placing a product on the market"
  },
  "roles": [
    {
      "id": "manufacturer",
      "label": "Manufacturer"
    },
    {
      "id": "importer",
      "label": "Importer"
    }
  ],
  "regulations": [
    "MDR"
  ],
  "path": [
    "regulation-library",
    "knowledge-articles"
  ],
  "trigger": "A wellness, fitness, beauty or health product is being launched, and its marketing mentions pain, sleep, stress, monitoring, therapy or a body function",
  "keep": "Technical documentation, the EU declaration of conformity and certificates for at least 10 years after the last device covered by the declaration is placed on the market; at least 15 years for implantable devices (Regulation (EU) 2017/745 Article 10(8))",
  "why": [
    {
      "text": "The Medical Devices Regulation, Regulation (EU) 2017/745, applies from 26 May 2021 (Article 123(2)). It covers medical devices and their accessories placed on the market, made available or put into service in the EU (Article 1(1)). A medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer for human beings for specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process; or providing information by in vitro examination of specimens (Article 2(1)).",
      "sources": [
        1
      ]
    },
    {
      "text": "The deciding word is \"intended\". The intended purpose is the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements, and as specified in the clinical evaluation (Article 2(12)). The same physical product can be a wellness product or a medical device depending on what its maker says it does. The regulation also forbids claims that mislead about the intended purpose, safety or performance, or that suggest uses beyond those assessed (Article 7).",
      "sources": [
        1
      ]
    },
    {
      "text": "Borderlines are set in the scope article. The regulation does not apply to medicinal products, and in deciding between the two, particular account is taken of the principal mode of action (Article 1(6)(b)); a device does not achieve its principal intended action by pharmacological, immunological or metabolic means (Article 2(1)). It does not apply to cosmetic products covered by Regulation (EC) No 1223/2009 (Article 1(6)(e)), which defines cosmetics by their cleaning, perfuming, appearance and care purposes (Regulation (EC) No 1223/2009 Article 2(1)(a)). Products with both a medical and a non-medical purpose meet both sets of requirements (Article 1(3)), and the Commission may decide the status of a product by implementing act (Article 4).",
      "sources": [
        1,
        2
      ]
    },
    {
      "text": "Some products are covered without a medical purpose. Annex XVI lists contact lenses and other items for the eye, products for modifying the anatomy through surgically invasive means, dermal fillers, equipment to reduce or destroy fat tissue, high-intensity electromagnetic radiation equipment such as lasers and intense pulsed light for skin resurfacing, tattoo or hair removal, and brain stimulation equipment. They fall under the regulation from the date of application of the common specifications for each group (Article 1(2)). Those common specifications are in Implementing Regulation (EU) 2022/2346, which applies from 22 June 2023 (Article 3); its Article 2, as amended in 2023, lets products already lawfully marketed before that date stay on the market until 31 December 2028, or 31 December 2029 where a clinical investigation is needed, if the conditions there are met.",
      "sources": [
        1,
        4
      ]
    },
    {
      "text": "If the product is a device, the work is substantial. Devices are classified in classes I, IIa, IIb and III under Annex VIII (Article 51). Manufacturers run a risk management system, a clinical evaluation, a quality management system and post-market surveillance, draw up technical documentation and a declaration of conformity, and keep them for at least 10 years, or 15 for implantables (Article 10). Class I devices are self-declared except sterile, measuring and reusable surgical devices (Article 52(7)). Devices certified under the old directives may still be placed on the market until 31 December 2027 or 31 December 2028, depending on class, if the conditions of Article 120(3a)–(3c) are met. The Commission has proposed amendments to the regulation (COM(2025) 1023); that is a proposal, not law. If it is not a device, other acts apply; for radio products, medical devices are excluded from the cybersecurity requirements of Delegated Regulation (EU) 2022/30 (Article 2(1)), so until that act is repealed on 11 December 2027 the qualification also decides which radio rules apply (Delegated Regulation (EU) 2026/339 Article 1).",
      "sources": [
        1,
        3,
        5
      ]
    }
  ],
  "steps": [
    {
      "name": "Write down the intended purpose as your materials state it",
      "text": "Collect the label, instructions, packaging, website, marketplace listings, sales scripts and social posts. The regulation reads the intended purpose from the data the manufacturer supplies on the label, in the instructions and in promotional or sales materials or statements, so all of them count.",
      "item": "knowledge-articles"
    },
    {
      "name": "Test that purpose against the medical purposes",
      "text": "A medical device is intended for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; for an injury or disability; for investigating or modifying the anatomy or a physiological process; or for control or support of conception. A product whose principal intended action is pharmacological, immunological or metabolic is not a device; it may be a medicinal product.",
      "item": "regulation-library"
    },
    {
      "name": "Check the Annex XVI list of non-medical products",
      "text": "Some products without a medical purpose are still under the regulation: coloured or other contact lenses, products for surgically modifying the anatomy, dermal fillers, equipment to reduce fat, high-intensity light equipment such as lasers and IPL for hair removal or skin treatment, and brain stimulation equipment."
    },
    {
      "name": "If it is a device, classify it and plan the route",
      "text": "Classify it in class I, IIa, IIb or III using the rules of Annex VIII. Class I devices can be self-declared after the technical documentation is drawn up, unless they are sterile, have a measuring function or are reusable surgical instruments. Higher classes need a notified body."
    },
    {
      "name": "If it is not a device, keep the claims consistent",
      "text": "Remove medical-purpose wording from every channel, because the intended purpose is read from your own materials. Then apply the acts that do cover the product, such as the General Product Safety Regulation or, for radio products, the Radio Equipment Directive."
    }
  ],
  "documents": [
    {
      "name": "A qualification note: intended purpose, the medical purpose test, Annex XVI check and conclusion",
      "from": "The manufacturer",
      "ground": "Regulation (EU) 2017/745 Articles 1(2), 2(1) and 2(12)"
    },
    {
      "name": "For a device: technical documentation, EU declaration of conformity and, where needed, notified body certificate",
      "from": "The manufacturer",
      "ground": "Regulation (EU) 2017/745 Articles 10(4), 10(6), 52 and Annexes II and III"
    }
  ],
  "risks": [
    {
      "title": "Misleading claims are prohibited",
      "text": "Labelling, instructions and advertising may not mislead the user or patient about the intended purpose, safety and performance, for example by ascribing functions the device does not have or suggesting uses outside the assessed intended purpose (Regulation (EU) 2017/745 Article 7).",
      "source": 1
    },
    {
      "title": "Online sale does not escape the rules",
      "text": "A device offered by means of information society services to a person established in the EU must comply with the regulation, and the seller must provide a copy of the EU declaration of conformity on request by a competent authority (Regulation (EU) 2017/745 Article 6(1) and (3)).",
      "source": 1
    },
    {
      "title": "Authorities can restrict or withdraw the device",
      "text": "If a manufacturer fails to cooperate or provides incomplete or incorrect information, the competent authority may prohibit or restrict the device on its market, withdraw it or recall it (Regulation (EU) 2017/745 Article 10(14)).",
      "source": 1
    }
  ],
  "faq": [
    {
      "q": "Is a fitness tracker a medical device?",
      "a": "It depends on the intended purpose the manufacturer gives it. Tracking steps for fitness is not a listed medical purpose; monitoring a disease is (Regulation (EU) 2017/745 Article 2(1)). The purpose is read from your label, instructions and promotional or sales materials (Article 2(12))."
    },
    {
      "q": "Can software be a medical device?",
      "a": "Yes. The definition includes software intended by the manufacturer for a medical purpose (Regulation (EU) 2017/745 Article 2(1)), and software is deemed an active device (Article 2(4))."
    },
    {
      "q": "We sell an IPL hair removal device. Is that under the MDR?",
      "a": "High intensity light equipment for hair removal or skin treatment is listed in Annex XVI, so it is covered as a product without a medical purpose since 22 June 2023, when the common specifications in Implementing Regulation (EU) 2022/2346 began to apply (Regulation (EU) 2017/745 Article 1(2) and Annex XVI point 5; Implementing Regulation (EU) 2022/2346 Article 3). Products already lawfully marketed before that date may benefit from transitional periods under conditions (Article 2 of that regulation)."
    },
    {
      "q": "Can a cream be a cosmetic and a medical device?",
      "a": "The regulation does not apply to cosmetic products covered by Regulation (EC) No 1223/2009 (Regulation (EU) 2017/745 Article 1(6)(e)). The qualification follows the intended purpose and how the product acts."
    },
    {
      "q": "Do class I devices need a notified body?",
      "a": "No, with three exceptions: devices placed on the market sterile, with a measuring function or as reusable surgical instruments need a notified body for those aspects (Regulation (EU) 2017/745 Article 52(7))."
    }
  ],
  "sources": [
    {
      "title": "Regulation (EU) 2017/745 on medical devices (consolidated text of 19 July 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20260719",
      "accessed": "2026-10-04"
    },
    {
      "title": "Regulation (EC) No 1223/2009 on cosmetic products (consolidated text of 18 May 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518",
      "accessed": "2026-10-04"
    },
    {
      "title": "Delegated Regulation (EU) 2022/30 on the application of Article 3(3)(d), (e) and (f) of Directive 2014/53/EU (consolidated text of 27 October 2023)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02022R0030-20231027",
      "accessed": "2026-10-04"
    },
    {
      "title": "Implementing Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 (consolidated text of 22 June 2023)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02022R2346-20230622",
      "accessed": "2026-10-04"
    },
    {
      "title": "Delegated Regulation (EU) 2026/339 repealing Delegated Regulation (EU) 2022/30",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R0339",
      "accessed": "2026-10-04"
    }
  ],
  "related": [
    "cosmetic-product-launch",
    "ppe-or-not",
    "connected-product-radio",
    "which-regulations-apply",
    "needs-ce-marking"
  ],
  "reviewer": "Conphora compliance team",
  "reviewedAt": "2026-10-04",
  "notice": "General information, not legal advice."
}