EVERBIZ · Compiled from official European Parliament, Council of the EU and European Commission documents
Industry sources attending recent meetings between EU Competent Authorities (CAs) and Notified Bodies (NBs) report that the EU is aiming to formally adopt the amendments to the MDR and IVDR in Q2–Q3 2027 (around summer 2027).
EVERBIZ has checked this point by point against the European Parliament’s Legislative Observatory, Council documents and the Commission’s original proposal:
① The amendment is still a proposal. It has not been adopted and has no date of entry into force.
② The current MDR (EU) 2017/745 and IVDR (EU) 2017/746 continue to apply in full.
③ None of the transition deadlines (end of 2027, 2028 and 2029) or the mandatory EUDAMED requirements have changed.
01 Where is the legislative process now?
The SANT committee’s draft report was published on 30 June 2026, and amendments were tabled on 28 July. At the time of writing, the Legislative Observatory still shows the status “Awaiting committee decision”.
Sources differ on the timing of the Parliament plenary vote: the Legislative Observatory lists an “indicative” plenary date of 14 December 2026; the Council’s June 2026 progress report says Parliament is aiming for early 2027; industry sources point to Q1 2027. Indicative dates often slip, so EVERBIZ recommends relying on Parliament’s official agenda.
The “Q2–Q3 2027” target refers to adoption only. It is not the date from which the new rules will apply.
02 Key dates
| Type of date | Date | What it refers to | Source |
|---|---|---|---|
| Publication | 16 Dec 2025 | Commission adopts and publishes amending proposal COM(2025) 1023 | European Parliament Legislative Observatory; text of the proposal |
| Adoption (target) | Q2–Q3 2027 | Formal adoption by Parliament and Council – a target, not a fixed date | Industry sources; no official timetable yet |
| Entry into force / application | Not yet determined | Can only be fixed once the amendment is published in the OJEU. Recital 58 of the proposal states that some provisions apply from entry into force and others later – e.g. the provisions on reprocessing single-use devices would apply 5 years after entry into force | Text of the proposal (Recital 58, Article 5 and related provisions) |
| Deadlines (currently in force) | 31 Dec 2027 / 31 Dec 2028 / 31 Dec 2029 | Current MDR/IVDR transition deadlines – see section 04 | Regulation (EU) 2023/607, (EU) 2024/1860 |
03 What does the proposal change? (Proposal only – the final text may differ)
The points below are taken from the Commission’s proposal. Parliament and Council may still amend or delete them:
- Certificate validity: the current maximum 5-year certificate validity is removed and replaced by risk-based periodic review by the notified body, with no full re-certification.
- Person responsible for regulatory compliance (PRRC): the detailed qualification requirements are deleted; an external PRRC used by an SME no longer has to be “permanently and continuously” at its disposal.
- Well-established technology devices: a new definition, subject to more proportionate requirements.
- Notified body involvement: technical documentation for Class IIa/IIb devices and Class B/C IVDs is sampled on a representative-device basis; sterile Class A IVDs no longer need a notified body; surveillance audits may take place every two years where there are no safety concerns, and remote audits are allowed.
- Vigilance and reporting: the reporting deadline for serious incidents not involving a public health threat, death or serious deterioration in health is extended from 15 to 30 days; periodic safety update reports (PSURs) are updated less often.
- Expert panel procedures: the clinical evaluation consultation procedure (CECP) is limited to Class III implantable devices; the IVDR performance evaluation consultation procedure (PECP) is abolished, and Class C/D manufacturers may instead request early advice from expert panels.
- Breakthrough and orphan devices: once designated by an expert panel, they can benefit from priority and rolling review.
- Digitalisation and AI: electronic declarations of conformity (DoC), partly electronic labelling and electronic instructions for use (eIFU) are permitted; AI devices would in principle no longer be subject to most provisions of the AI Act on top of the MDR/IVDR, with the relevant requirements set within the MDR/IVDR framework instead.
Note: According to industry sources, some competent authorities and notified bodies are concerned that these relaxations, taken together, could affect device safety and quality; the Council’s progress report also records similar reservations from Member States. Any of the points above may be changed during negotiations.
04 Deadlines that are still counting down
These dates are set by the current regulations and are not changed by the amending proposal. Do not pause your transition because the rules are “being simplified”:
| Scope | Deadline | Requirement |
|---|---|---|
| MDR legacy devices: Class III and Class IIb implantable devices (except certain WET products) | 31 Dec 2027 | MDR certificate required; the conditions for the extension (application lodged by 26 May 2024, written agreement signed by 26 Sep 2024) have already expired |
| MDR legacy devices: other Class IIb, Class IIa, Class Is/Im/Ir | 31 Dec 2028 | As above |
| IVDR Class D | 31 Dec 2027 | Application and agreement milestones (26 May 2025 / 26 Sep 2025) have passed |
| IVDR Class C | 31 Dec 2028 | Application and agreement milestones (26 May 2026 / 26 Sep 2026) have passed |
| IVDR Class B and sterile Class A | 31 Dec 2029 | Application to a notified body by 26 May 2027 and written agreement signed by 26 Sep 2027 |
| First four EUDAMED modules (actor registration, UDI/device registration, notified bodies and certificates, market surveillance) | Mandatory from 28 May 2026 | Devices placed on the market before 28 May 2026 and still being made available must be registered within 12 months of the official notice (published 27 Nov 2025) |
EVERBIZ will continue to follow the Parliament vote, the Council’s general approach and the trilogue negotiations, and will publish updates promptly. If you need an EU Authorised Representative, EUDAMED registration or support with your MDR/IVDR transition, please contact us.
Original content by EVERBIZ · Please credit the source when republishing