IVDR - Regulation (EU) 2017/746

What IVDR is and why it matters

The In Vitro Diagnostic Regulation (IVDR) — formally Regulation (EU) 2017/746 on in vitro diagnostic medical devices — is the EU’s framework for the devices used to examine samples taken from the human body, from blood-test analysers and pregnancy tests to companion diagnostics, infectious-disease assays and the COVID tests that became household items. If you place an in vitro diagnostic (IVD) on the EU market, IVDR almost certainly governs how you do it. The Regulation sets out how these devices are classified, what evidence must back up their performance, how they are assessed before sale, and how they are tracked and monitored once they are in use.

IVDR matters because it is a step change from the regime it replaced. The old IVD Directive 98/79/EC let manufacturers self-certify the large majority of diagnostics, with a notified body involved only for a short list of high-risk products. IVDR inverts that picture: it introduces a risk-based classification system and requires notified-body involvement for most devices. For many manufacturers that means external conformity assessment for the first time, stronger clinical and performance evidence, and continuous post-market obligations. It closely parallels the Medical Device Regulation (MDR), its sister law for medical devices.

📄 Official text: Regulation (EU) 2017/746 on in vitro diagnostic medical devices — on EUR-Lex →

Who IVDR applies to

IVDR applies across the supply chain, with duties that scale by role but reach every link:

Manufacturers — anyone who makes an IVD, or has it made and markets it under their own name or trademark. They carry the heaviest obligations, including classification, technical documentation, performance evaluation and the declaration of conformity.
Authorised representatives — the EU-based actor a non-EU manufacturer must appoint to take on defined legal responsibilities and act as the point of contact for authorities.
Importers — businesses bringing IVDs from outside the EU into the Union market. They must verify the manufacturer has met its obligations, that the CE marking and documentation are in place, and that an authorised representative is designated.
Distributors — wholesalers and retailers further down the chain who must act with due care, check that required markings and documents are present, and not supply devices they know or should presume to be non-compliant.

The Regulation also covers in-house (“laboratory-developed”) tests made and used within a single health institution, subject to specific conditions, and brings software and companion diagnostics clearly within scope.

Key dates and timeline

5 May 2017 — Regulation (EU) 2017/746 was adopted and entered into force, starting a transition period for the sector to adapt.
26 May 2022 — IVDR applies from this date, replacing the IVD Directive 98/79/EC. From this point the Regulation’s obligations are the legal baseline for placing IVDs on the EU market.
Extended transitional periods — because notified-body capacity and readiness were limited, the dates of application were amended by Regulation (EU) 2022/112 (and adjusted again in later amendments) to give legacy devices staggered, risk-based extensions for continued sale while manufacturers complete IVDR conformity assessment. The higher the risk class, the earlier the deadline.

Because IVDR is a regulation, it is directly applicable in all Member States without national transposition, reducing the variation that existed under the old directive.

Core requirements

Risk-based classification (A, B, C, D)

IVDR sorts every device into one of four classes using rules set out in the Regulation. Class A covers the lowest-risk products (such as general laboratory reagents and instruments); Class B and Class C cover progressively higher risk; and Class D covers the highest-risk devices, typically those used to detect transmissible agents in blood and organs or life-threatening conditions. The class drives almost everything that follows — the depth of evidence required, whether a notified body is involved, and the level of scrutiny applied. Getting classification right is the first and most consequential decision under IVDR.

Notified-body conformity assessment

This is the defining shift from the old directive. Under IVDR, Classes B, C and D require involvement of a notified body in conformity assessment; only the lowest-risk Class A devices (other than sterile ones) can generally be self-certified by the manufacturer. In practice this means the large majority of diagnostics now need an independent, EU-designated notified body to review the quality management system and, depending on class, the technical documentation and performance evidence before the device can be CE marked. Class D devices face the most rigorous route, which can include scrutiny by EU reference laboratories and expert panels.

Performance evaluation and performance studies

Every IVD must be supported by a performance evaluation demonstrating its scientific validity, analytical performance and clinical performance for its intended purpose. Where existing data is not enough, manufacturers must conduct performance studies to generate it, following the Regulation’s rules on study conduct and, where applicable, ethics and oversight. The evidence is assembled into a performance evaluation report that is part of the technical documentation and is kept up to date throughout the device’s life.

EUDAMED and UDI

IVDR is built around traceability. Each device carries a Unique Device Identifier (UDI) that allows it to be identified and tracked through the supply chain and in use. Manufacturers, authorised representatives, importers and devices are registered in EUDAMED, the European database on medical devices, which brings together registration, certificates, UDI data, vigilance and market surveillance information. UDI and EUDAMED together let authorities and operators locate affected devices quickly when something goes wrong.

Post-market surveillance and vigilance

Compliance does not end at the CE marking. Manufacturers must run a post-market surveillance system proportionate to the device’s risk class, actively gathering and analysing real-world performance and safety data, and feeding it back into the technical documentation. They must operate vigilance processes to report serious incidents and field safety corrective actions to the competent authorities, and produce periodic safety and performance reports where required. The aim is a living evidence base rather than a one-time approval.

Obligations by role

Manufacturers — classify the device, build and maintain technical documentation and the performance evaluation, secure notified-body assessment where required, draw up the declaration of conformity, affix CE marking, assign UDIs and run post-market surveillance and vigilance.
Authorised representatives — verify the declaration and documentation, register in EUDAMED, cooperate with authorities and act for the non-EU manufacturer.
Importers — check the CE marking, declaration, UDI and authorised representative are in place, add their own identification and refuse non-compliant devices.
Distributors — verify markings and documents are present, store and transport devices appropriately, and stop supply of devices they believe to be non-compliant.

Enforcement

Each Member State designates a competent authority to oversee IVDR. In Denmark, the Danish Medicines Agency (Lægemiddelstyrelsen) is the competent authority for in vitro diagnostic medical devices, handling registration, market surveillance and vigilance. Notified bodies, in turn, are designated and monitored under the Regulation to carry out conformity assessment.

Authorities can require corrective action, restrict or suspend devices, order withdrawals and recalls, and pursue penalties set at national level. Vigilance reports and field safety corrective actions are shared so that a problem identified with a device in one country can trigger coordinated action across the Union. For a manufacturer, the qualitative reality is that a serious incident or a failed assessment can halt sales across multiple markets at once.

Getting compliant

Confirm your product is an IVD under IVDR and determine its risk class (A, B, C or D).
Engage a notified body early if your device is Class B, C or D — capacity is limited and timelines are long.
Build the technical documentation and the performance evaluation, conducting performance studies where the evidence gap requires it.
Appoint an EU authorised representative if you are based outside the EU.
Assign UDIs and register your organisation and devices in EUDAMED.
Draw up the declaration of conformity and affix the CE marking once assessment is complete.
Stand up post-market surveillance and vigilance processes, and track the transitional deadlines that apply to your device class.

How Conphora helps

Conphora monitors IVDR and maps your products against its requirements, flagging gaps in classification, performance evidence, notified-body assessment, UDI and EUDAMED registration before they become enforcement problems. The platform helps you generate and keep the right documentation, and alerts you when obligations or transitional deadlines change so your compliance stays current.

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Sources and further reading

This guide is for general information and is not legal advice.

Last updated: 12 June 2026