EU Medical Device Regulations: MDR and IVDR Explained

The European Union regulates medical devices through two main regulations: the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). Together they define what a manufacturer must do to place a CE-marked device on the EU market. This guide gives a clear map of the framework: who does what, how devices are classified, what the conformity route looks like and what is changing.

The legal framework at a glance

Regulation	Covers	Date of application
MDR (EU) 2017/745	Medical devices and their accessories, and certain products without a medical purpose listed in Annex XVI	26 May 2021
IVDR (EU) 2017/746	In vitro diagnostic medical devices	26 May 2022, with phased transition periods

These replaced the earlier directives (MDD, AIMDD and IVDD). As regulations, they apply directly in all member states. Supporting guidance comes from the Medical Device Coordination Group (MDCG), and harmonised standards give a presumption of conformity with relevant requirements.

Who is responsible: the economic operators

• Manufacturer: holds the main responsibility for design, conformity, technical documentation, quality system, PMS and vigilance.
• Authorised representative: required for manufacturers outside the EU.
• Importer and distributor: verify the device is CE-marked, labeled and accompanied by documentation, and maintain traceability.
• Person responsible for regulatory compliance (PRRC): required under Article 15 with defined qualifications.
• Notified body: an independent organisation designated to assess conformity for most devices above Class I.

Classification under the MDR

MDR Annex VIII sets 22 classification rules, which place devices into Class I, IIa, IIb or III, with sub-classes I-sterile, I-measuring and I-reusable surgical. Classification depends on intended purpose, duration of contact, invasiveness, whether the device is active and which part of the body it affects. Software is often classified under Rule 11, which tends to raise the class compared with the old directives. See Is my software a medical device? for qualification and classification.

Conformity assessment and CE marking

1. Qualify and classify the product and choose the conformity assessment route in Annexes IX to XI.
2. Meet the General Safety and Performance Requirements (GSPR) in Annex I, supported by risk management, usability, biocompatibility, electrical safety, software and other standards.
3. Build the technical documentation to Annexes II and III. See EU MDR technical documentation.
4. Run a quality management system as required by Article 10(9), commonly certified to ISO 13485.
5. Complete a clinical evaluation under Article 61 and Annex XIV and plan PMCF. See PMCF under EU MDR.
6. Involve a notified body where required, then issue the EU declaration of conformity and affix the CE mark.
7. Register the manufacturer and devices, assign Unique Device Identifiers and run post-market surveillance and vigilance.

EUDAMED and UDI

EUDAMED is the European database for devices. The Commission published a notice establishing that the first four modules (actor registration, UDI and device registration, notified bodies and certificates, and market surveillance) became mandatory from 28 May 2026. The remaining modules, including vigilance and clinical investigations, follow separately. UDI requires labeling with unique device identifiers and registration in the UDI database. Check the Commission’s EUDAMED pages and MDCG guidance for current obligations and timelines.

Transitional arrangements for legacy devices

Regulation (EU) 2023/607 extended the period during which devices with valid directive certificates can continue to be placed on the market, provided conditions are met (including a signed written agreement with a notified body and a compliant quality system). The outer dates are 31 December 2027 for higher-risk devices (Class III and Class IIb implantable devices) and 31 December 2028 for other Class IIb, IIa and Class I devices requiring notified body involvement. The Commission has also proposed targeted simplification of the MDR and IVDR; the proposal is going through the EU legislative process, so follow the official sources for its status. Our article on EU MDR compliance challenges explains where teams most often get stuck.

How the EU compares with the US

The EU relies on notified bodies and CE marking, with self-declaration for the lowest risk class. The US uses FDA premarket review (510(k), De Novo or PMA). Both expect a quality system, risk management, clinical evidence and post-market monitoring. Read our overview of US FDA device regulations and the comparison FDA vs EU MDR.

Frequently asked questions

What is the difference between MDR and IVDR?

The MDR covers medical devices, while the IVDR covers in vitro diagnostic devices such as tests and analysers. The IVDR introduced a new risk-based classification (Classes A to D) with much greater notified body involvement than the earlier directive.

Do I need a notified body?

For most devices above the lowest class, yes. Class I non-sterile, non-measuring, non-reusable devices can be self-certified by the manufacturer. Always confirm your route against the classification rules and conformity annexes.

Do non-EU manufacturers need an authorised representative?

Yes. Manufacturers outside the EU must appoint an EU authorised representative, and importers have their own obligations.

Is ISO 13485 mandatory under the MDR?

The MDR requires a quality management system, and ISO 13485 is the standard most manufacturers and notified bodies use to demonstrate it. Certification is expected for most notified body routes.

EU requirements and deadlines change. Verify dates and obligations against EUR-Lex, the European Commission and MDCG guidance before acting on them.

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