December “In All Other News”: Draft Act to Revise NB Requirements, New MDCG Docs, & more
7 January 2026
MDR/IVDR Reform Updates: WTO Publication & Redlined Versions
16 January 2026Background
Last month, the Commission published its proposal to amend the MDR and IVDR.
Reform proposal COM(2025)1023 includes significant changes, including:
- Reclassification of devices, such as software, reusable surgical instruments, and “well-established technologies”.
- Proposes to remove CE Marking certificate expirations, instead maintaining CE Marking with periodic reviews, which should be proportionate to the risk class of the device.
- Reduce surveillance audits from once per year, to every two years (where justifiable), and reduce the number of technical documentation files that must be reviewed within each generic device group/product category (as applicable).
- Remove Notified Body involvement for reusable surgical instruments (if conditions are met) and Class A sterile IVDs.
- Reduce PSUR obligations.
- Introduce additional non-clinical sources of data under Article 61 of the MDR.
- Reduced Notified Body fees for micro (50%) and small (25%) sized enterprises, and greater Notified Body fee transparency overall.
- Expand Notified Body structured dialogues, e.g., to allow pre-submission discussions on clinical data acceptability.
- Allow the European Commission to participate in international reliance programs, such as those the UK MHRA is developing.
How to Provide Feedback
Today, the Commission opened an 8-week feedback period on its proposal: HERE
Interested parties can submit their comments on the draft legislation between 07 January 2026 – 04 March 2026 (midnight Brussels time).
As noted in the link: “All feedback received will be summarised by the European Commission and presented to the European Parliament and Council with the aim of feeding into the legislative debate.”
In layman’s terms, this means that the European Parliament and the Council will each discuss the draft act and the feedback received, and potentially draft amendments / propose changes. If so, these proposed revisions will then be discussed during trilogue negotiations between Parliament, the Council, and the Commission.
As of today, the process is still in an input-gathering phase before any formal legislative negotiations can begin.
