The Commission's MDR/IVDR proposal is on the table, Parliament has filed more than 130 amendments, and nothing is final before 2027. Dr. Bassil Akra and Michael Kania go through what the proposal actually says, where Parliament wants to change it, and what you can prepare today that holds up regardless of which version becomes law.
All editions
The Regulatory RoomEdition 1
MDR & IVDR 2.0 Revision
What you can prepare today that holds up regardless of which version becomes law
Hosted by Michael Kania
Recorded September 18, 2026Language: English
Preview
About this session
Materials
Available after registration- Document
Session Brief - MDR & IVDR 2.0 The Regulatory Room
The written summary of the live session. What was discussed, what changes, the deadlines on one timeline, and an action list with owners for RA, QM and Clinical teams.
Download - Academy course
MDR & IVDR 2.0 - What to expect and how to prepare
The EU Commission has proposed the biggest overhaul of the MDR and IVDR since they took effect. Follow Vera, a Head of Regulatory Affairs, through the eight reform areas of COM(2025) 1023: what would change, what stays, where the legislative process stands and what your team should (and should not) do about it today.
Open course
Sources and further reading
- COM(2025) 1023: Commission proposal to amend MDR and IVDRThe proposal itself, published 16 December 2025. Articles, recitals and the entry-into-force provisions. Start here; everything else is commentary.
- Implementing Regulation (EU) 2026/977: notified body timelines and proceduresAdopted 4 May 2026, applies from 25 February 2027. Maximum assessment timelines, clock-stop rules and transparent quotations for notified bodies under MDR and IVDR.
- Commission study and dashboard: availability of medical devices on the EU marketSource of the notified body survey figures in the Brief (32,898 MDR applications, 18,010 certificates as of February 2026). Dashboard updates roughly every two months.
- Legislative Observatory: procedure file 2025/0404(COD)The Parliament's official tracker for rapporteur, committee documents and vote dates. Check here before believing any date in a newsletter.