Entering the European Union

Classification and routes

The MDR classifies devices into Class I (with sub-categories for sterile, measuring and reusable surgical devices), IIa, IIb and III under the 22 rules of Annex VIII; the IVDR classifies IVDs into Classes A to D under its own Annex VIII. The class decides the conformity-assessment route and therefore how much of the file a notified body reviews. Only Class I devices that are not sterile, measuring or reusable surgical, and IVD Class A devices that are not sterile, self-certify; everything else involves a notified body, from a quality-system audit with technical-documentation sampling to a full design examination. Classification is the first decision in any EU plan and the one most often got wrong by a single sentence of intended purpose.

Technical documentation and evidence

Annex II and III set out the technical documentation: device description and specification, information supplied by the manufacturer, design and manufacturing information, the general safety and performance requirements with the method and evidence for each, benefit-risk and risk management, verification and validation (including biocompatibility, electrical safety, software, usability, stability and the clinical evaluation or performance evaluation), and the post-market documentation. The clinical evaluation under Articles 61 and 62 and Annex XIV, and the performance evaluation under IVDR Articles 56 and 57 and Annex XIII, are living documents fed by PMCF or PMPF. See technical documentation for how the file is built and traced.

Actors, representation and EUDAMED

A non-EU manufacturer appoints an Authorised Representative in the EU under Article 11; the mandate is a legal instrument and the representative carries obligations and potential liability. Every manufacturer has a Person Responsible for Regulatory Compliance under Article 15. Importers and distributors have verification duties under Articles 13 and 14. The manufacturer, the representative and the importer each register in EUDAMED's Actor module and receive a Single Registration Number; devices are registered with their Basic UDI-DI and UDI-DIs in the UDI/Device module before being placed on the market. Since 28 May 2026 these registrations are mandatory and national registers no longer satisfy them; devices already on the market before that date had until 28 November 2026 to be registered.

PMS, PSUR and vigilance

Class I devices need a PMS report under Article 85; Class IIa devices a PSUR under Article 86 at least every two years; Class IIb and III a PSUR at least annually, with IIb implantable and Class III PSURs going to the notified body. IVD Class C and D devices need a PSUR under IVDR Article 81. Serious incidents and field safety corrective actions are reported under Articles 87 to 89 within the statutory timelines, through national routes until EUDAMED's Vigilance module is mandated. Trend reporting under Article 88 needs a method and thresholds. See post-market surveillance.

The targeted revision and the AI Act

Two legislative developments sit over every EU plan in 2026. The Commission's proposal for a targeted revision of the MDR and IVDR (COM(2025) 1023, procedure 2025/0404(COD)) was published on 16 December 2025; Parliament's rapporteur issued a draft report on 1 July 2026, and adoption is targeted for 2027. It is a proposal: the current text applies until an amending regulation is adopted and in force, and a file built to the current requirements will be well placed under any likely outcome.

The AI Act, as amended by the Digital Omnibus on AI (Regulation (EU) 2026/1744, in force 27 July 2026), classifies AI that is a device or a safety component of one requiring notified-body assessment as a high-risk AI system under Article 6(1), with obligations applying from 2 August 2028; Annex III standalone high-risk systems apply from 2 December 2027. The classification route determines the date, and the software pillar states both.

Sequence of steps

1. Classify the device under Annex VIII and document the rule applied.
2. Appoint the Authorised Representative and the PRRC; register as an actor in EUDAMED and obtain the SRN.
3. Select the notified body and open the structured dialogue.
4. Build the technical documentation to Annex II and III, including the clinical or performance evaluation and the PMS plan.
5. Bring the quality system to ISO 13485:2016 and the MDR's Article 10 requirements.
6. Undergo conformity assessment; receive the certificate; draw up the EU declaration of conformity; affix the CE mark.
7. Register devices in EUDAMED before placing on the market; assign Basic UDI-DI and UDI-DIs.
8. Run PMS, PSUR, PMCF or PMPF and vigilance on the cadence the class requires; keep the clinical or performance evaluation current.

Dated changes to know about

Legal basis and references