EU MDR 2017/745 · 2026 Edition
EU MDR replaced the MDD in 2021 and changed how devices reach the European market. This guide covers classification, clinical evidence, PMCF, Notified Body submission, and every key update through 2026, for RA managers and decision-makers.
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CERs and technical documentation under EU MDR and MEDDEV 2.7/1 Rev 4.
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EU MDR is not static. The Commission, MDCG and Notified Bodies keep issuing guidance and updates that affect anyone with a CE-marked device or an active transition programme. These are the developments to track in 2026.
Clarifies how EU MDR 2017/745 and the EU AI Act (Regulation 2024/1689) interact for AI-based medical devices (SaMD). For AI SaMD classified as high-risk under the AI Act, manufacturers must address both the MDR conformity assessment pathway and the AI Act technical documentation requirements simultaneously. Notified Bodies are expected to assess AI Act compliance as part of the MDR QMS review for relevant devices.
The Commission extended the transitional provisions for legacy MDD-certified devices. Devices certified under the MDD before the transition deadline may continue to be placed on the market until class-dependent dates — generally around December 2027 for higher-risk and December 2028 for lower-risk devices, subject to conditions including Notified Body availability. Manufacturers need an active EU MDR transition plan to benefit.
EUDAMED continues to expand its mandatory functionality. UDI-DI registration is now required before device sale in the EU, and clinical investigation registration — including SADE reporting and annual progress reports — is mandatory for EU MDR clinical investigations. Manufacturers without EUDAMED accounts and UDI management face compliance gaps.
The essentials
01
EU MDR replaced the Medical Device Directive (MDD 93/42/EEC) in 2021 and fundamentally changed how devices reach the European market. It raised the bar on clinical evidence, tightened classification, made PMCF proactive and mandatory, expanded Notified Body oversight and introduced end-to-end traceability through UDI and EUDAMED.
02
Devices are classified by risk — Class I, IIa, IIb and III — using rules based on intended purpose, duration of contact, invasiveness and whether the device is active or delivers a medicinal product. The class drives everything downstream.
Class determines
03
The shift is from passive to continuous, evidence-based compliance. EU MDR demands stronger clinical evidence and proactive PMCF, reclassifies several device types upward, requires a Person Responsible for Regulatory Compliance, adds UDI and EUDAMED traceability, tightens equivalence, and introduces the CECP for the highest-risk devices.
04
Across the lifecycle, four pillars carry the file:
A robust CER that justifies every IFU claim against the state of the art.
Unique Device Identification and database registration before market access.
An ISO 13485 QMS and a qualified PRRC accountable for conformity and vigilance.
EU MDR at a glance
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