What the EU MDR is
The EU Medical Device Regulation, Regulation (EU) 2017/745, governs how medical devices are placed on the market in the European Union. It replaced the Medical Device Directive and the Active Implantable Medical Device Directive and has applied since May 26, 2021. Compared with the old directives, it tightened requirements on clinical evidence, notified body oversight, post-market surveillance, traceability through UDI, and transparency through the EUDAMED database.
For US manufacturers, the MDR is the gateway to a market of about 450 million people. It is also a moving target: 2026 brought mandatory EUDAMED use, approaching transition deadlines and a formal proposal to simplify the regulation itself.
Where the EU MDR stands in 2026
Transition deadlines
Regulation (EU) 2023/607 extended the transition for legacy devices certified under the old directives. The amended Article 120 sets “31 December 2027, for all class III devices” and class IIb implantables (with listed exceptions), and “31 December 2028, for class IIb devices other than those covered by point (a)”, along with class IIa and class I sterile or measuring devices (EUR-Lex).
The extension was conditional. Manufacturers had to lodge a formal application with a notified body “no later than 26 May 2024”, sign a written agreement “no later than 26 September 2024”, and have “put in place a quality management system” by May 26, 2024 (same source). Legacy devices that missed these steps can no longer rely on the extension.
EUDAMED is now mandatory
The Irish competent authority HPRA confirms that “Mandatory use of four EUDAMED modules for medical devices begins on 28 May 2026”: actor registration, UDI/device registration, notified bodies and certificates, and market surveillance (HPRA). Under Regulation (EU) 2024/1860, device registration obligations run on a 12-month window from the Commission’s notice (EUR-Lex), so data quality in EUDAMED is now a compliance issue.
The Commission’s simplification proposal
On December 16, 2025, the European Commission proposed “a targeted simplification of the current rules for medical devices” (European Commission). Law firm Crowell & Moring summarizes key elements: “The maximum period of validity for certificates (currently five years) is removed,” and “Instead of recertifying devices, notified bodies will carry out periodic reviews proportionate to the risk of the device” (Crowell & Moring). The proposal would also move MDR and IVDR devices to Section B of Annex I of the AI Act.
The proposal is not law. As of July 2026, the Council was “aiming to reach a General Approach by the end of 2026,” and “the European Parliament is expected to adopt its position in early 2027” (DSV Europe). Until a final text is adopted, current MDR requirements apply in full.
Notified body capacity
The Commission’s notified body survey, with data up to February 28, 2026, counts 32,898 MDR applications, 18,010 MDR certificates and 52 notified bodies designated under the MDR (European Commission NB survey). Capacity has improved since 2021, but the gap between applications and certificates means review queues remain a planning risk.
| Milestone | Date | What it means |
|---|---|---|
| MDR date of application | May 26, 2021 | New devices must comply with the MDR |
| Legacy extension conditions | May 26 and Sep 26, 2024 | Application, NB agreement and QMS deadlines for using the extension |
| Simplification proposal | Dec 16, 2025 | Commission proposal; legislative process ongoing |
| EUDAMED mandatory modules | May 28, 2026 | Four modules must be used |
| Class III and IIb implantable legacy deadline | Dec 31, 2027 | Legacy certificates end for these classes |
| Other legacy deadline | Dec 31, 2028 | Other IIb, IIa, and class I sterile or measuring devices |
What EU MDR compliance requires
| Area | Key MDR requirements |
|---|---|
| Classification | Classes I, IIa, IIb and III per Annex VIII rules |
| QMS | Article 10 QMS covering regulatory strategy, risk, clinical evaluation, PMS, vigilance; ISO 13485 is the usual basis |
| Technical documentation | Annex II and Annex III files, kept up to date (Article 10(4)) |
| Clinical evaluation | Article 61 and Annex XIV, guided by MDCG documents such as MDCG 2020-5 on equivalence |
| Conformity assessment | Annex IX to XI routes, with a notified body for most devices above class I |
| People | A person responsible for regulatory compliance (Article 15); an EU authorised representative for non-EU makers (Article 11) |
| UDI and EUDAMED | UDI assignment and registration in EUDAMED |
| Post-market | PMS plan, PSUR or PMS report, vigilance and trend reporting |
A compliance roadmap for US manufacturers
- Confirm classification under Annex VIII and current MDCG classification guidance (MDCG 2021-24 rev.1 was updated in April 2026).
- Appoint an EU authorised representative and PRRC. Article 11 states that a non-EU manufacturer’s device “may only be placed on the Union market if the manufacturer designates a sole authorised representative” (EUR-Lex).
- Extend your QMS. If you run an ISO 13485-based QMS for the QMSR, add MDR-specific processes: PMS, vigilance, PRRC duties, UDI and EUDAMED.
- Build the technical documentation to Annex II and III, with a GSPR checklist that links each requirement to specific evidence.
- Plan clinical evidence early. Clinical evaluation is the most common reason for long notified body reviews.
- Book notified body capacity and plan for multiple question rounds.
- Register in EUDAMED and keep UDI data current.
- Track the simplification proposal but do not plan on it; current rules apply until a final regulation is adopted.
EU MDR compliance checklist
- Device classification documented with rule rationale
- Authorised representative and PRRC appointed
- QMS covers MDR Article 10 elements, including PMS and vigilance
- Annex II and III technical documentation complete and searchable
- GSPR checklist links each requirement to specific evidence
- Clinical evaluation plan and report current
- Notified body contract and timeline agreed
- UDI assigned and EUDAMED registrations complete
- Legacy device transition status confirmed against 2027 and 2028 deadlines
- Simplification proposal monitored for adoption
Check MDR documents before your notified body does
Notified bodies most often delay reviews because information is missing, inconsistent or hard to find. AI document assessment can check technical documentation, clinical evaluation reports and procedures against MDR requirements or your GSPR checklist, flag gaps and inconsistencies, and cite the passage behind every finding.
Run a sample EU MDR document assessment on one section of a technical file. AskDona shows the evidence; your regulatory team decides.
FAQ
What is the EU MDR? Regulation (EU) 2017/745, the EU law that governs medical devices placed on the EU market.
When is the EU MDR deadline? New devices must already comply. For eligible legacy devices, the deadlines are December 31, 2027 for class III and class IIb implantables and December 31, 2028 for other classes (EUR-Lex).
Is the EU MDR being changed? The Commission proposed a targeted simplification in December 2025; it is still going through the EU legislative process.
Is EUDAMED mandatory? Yes, four modules became mandatory on May 28, 2026 (HPRA).
Do US companies need an EU representative? Yes. Non-EU manufacturers must designate a sole authorised representative under Article 11.
References
All pages opened and checked by October 13, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| EUR-Lex: Regulation (EU) 2023/607 | Regulation | Mar 20, 2023 | Transition deadlines |
| EUR-Lex: Regulation (EU) 2024/1860 | Regulation | Jul 9, 2024 | EUDAMED rules |
| EUR-Lex: Regulation (EU) 2017/745 | Regulation | May 5, 2017 | Articles 10, 11, 15 |
| HPRA: Mandatory EUDAMED modules | Competent authority | Mar 23, 2026 | EUDAMED date |
| European Commission: MDR overview | Regulator | 2026 | Simplification proposal |
| Crowell & Moring: Simplification proposal | Law firm | Dec 22, 2025 | Proposal content |
| DSV Europe: MDR/IVDR revision status | Stakeholder organization | Jul 24, 2026 | Legislative status |
| European Commission: NB survey | Regulator | Jul 2, 2026 | Certificates and applications |