EUDAMED Officially Published Today: What Manufacturers Need to Know
26 November 2025
EU Device Reform Package: Fee Relief, Down-Classification, and More
16 December 2025- Europe Updates
- EU Manufacturer Incident Report (MIR) Form 7.3.1 Delayed
- MDCG Working Group 24-25 Sep 2025 Meeting Minutes
- MDCG 2025-8 on Master UDI-DI for spectacles
- New ‘Have your say’ Simplification – Digital Package and Omnibus
- Pilot coordinated assessment for Clinical Investigation/Performance Studies
- New Team Notified Body MDR Clinical Training
- UK Updates
- Switzerland Updates
Below is an overview of the November 2025 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., the publication of EUDAMED in the Official Journal.
Europe Updates
EU Manufacturer Incident Report (MIR) Form 7.3.1 Delayed
Background
In May 2025, the Commission published Manufacturer Incident Report (MIR) Form 7.3.1, noting that its use would become mandatory in 6-months. After which time, MIR Form 7.2.1 would be retired.
The Update
The EU Commission vigilance webpage now states that the MIR form 7.3.1 will become mandatory “as from 4 months after the date of the publication of the next update of MIR 7.3.1. PDF and related files”.
What does this mean in plain language?
Finland Competent Authority (Fimea) provided clarifying information, advising that MIR Form 7.3.1 is still in the process of being revised, and an updated version is expected to be published by end of 2025. Once published, its use will become mandatory 4 months later. For example, if it is published 30 December 2025, its use will become mandatory on 1 May 2026.
MDCG Working Group 24-25 Sep 2025 Meeting Minutes
The meeting minutes and presentations from the stakeholder meeting are here, and the one without stakeholders included are here.
Some notable items from the meetings are summarized below:
- Targeted revision of the MDR/IVDR: publication of the proposal is still planned for December 2025 (pending internal validation being completed in time).
- Internal discussions on: reduction of administrative burden; more proportionate MDR and IVDR requirements; support innovation; enhance predictability and cost-efficiency of certification; governance & organization of the EU regulatory system; further digitalization; international cooperation and reliance; better alignment with other legislations.
- The Notified Body requirements implementing act: planned for adoption in Q1 2026. It will include “timelines for conformity assessment, requirements for a reliable quotation, monitoring of timelines and costs and recertification”.
- Adoption of the Well-Established Technologies (WET) list: expansion is planned for December 2025. As of September, the list of technologies were under discussion within a dedicated MDCG Task Force.
- Structured Dialogues: Currently limited in scope, Notified Bodies and industry groups have called for structured dialogues to be allowed pre-submission, particularly in regard to adequacy of clinical data. The Commission noted that they intend to feed this item into the MDR/IVDR reform, as opposed to the implementing act on Notified Body requirements.
- Non-legislative short-term actions – in principle on hold for now: guidance on breakthrough technologies (BtX); guidance on orphan IVDs, sampling of technical documentation, certificates under conditions, and structured dialogues; IMDRF guidance, e.g., good machine learning practices, pre-determined change control plans; MDSAP mapping activities; and support to other activities such as Horizon scanning and orphan devices.
- Notified Body Capacity: Team Notified Body (NB) self-reported that NBs currently have more than sufficient capacity, and in fact, some NBs are even scaling down due to reduced workload.
MDCG 2025-8 on Master UDI-DI for spectacles
MDCG 2025-8, newly published 13 November 2025, is available: HERE
It covers guidance on Master UDI-DI for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles.
New ‘Have your say’ Simplification – Digital Package and Omnibus
The new initiative is published: HERE
The Digital Omnibus is the Commission’s initiative to simplify the EU’s complicated web of digital regulations. “Omnibus” means it’s a package that amends multiple existing laws at once, rather than creating new standalone legislation.
What does this mean in plain language?
Manufacturers are dealing with an increasingly complex regulatory landscape, where many digital rules overlap: the AI Act, the Cyber Resilience Act, certain MDR/IVDR requirements, GDPR for health data, and more.
This creates confusion about which rules apply when, how they interact, and how to comply with the various overlapping requirements. The Omnibus aims to resolve this.
Proposal to revise the AI Act: this proposal is part of the Omnibus package. Some of the changes include:
- Link the implementation of high-risk rules to the availability of standards or other supporting tools. This is important, as industry learned when the MDR and IVDR went into effect without EUDAMED, MDCG guidance, sufficient Notified Body capacity, etc.
- Extending regulatory simplifications granted to small and medium-sized enterprises (SMEs) to small mid-caps (SMCs), including simplified technical documentation requirements and special consideration in the application of penalties.
- Clarify the interplay between the AI Act and other EU legislation, and adjust the AI Act’s procedures to improve its overall implementation and operation.
- Develop guidance, e.g., on the practical application of the high-risk classification, and post-market monitoring of high-risk AI systems.
MedTech Europe published its feedback on the Digital Omnibus package. Among other items, they cite the need for better alignment between AI Act and MDR/IVDR, clearer definition of “substantial modification”, and requests a timeline extension, from August 2028 to August 2029 for AI medical devices.
Pilot coordinated assessment for Clinical Investigation/Performance Studies
The Commission initiated a pilot to coordinate assessment for clinical investigations (medical devices) and performance studies (IVDs): HERE
This pilot allows sponsors to submit a single application for coordinated assessments, which should reduce discrepancies in assessment due to different national interpretations, and enable faster decisions at the national level.
New Team Notified Body MDR Clinical Training
Team Notified Body (NB) has scheduled another ½ day training session on MDR clinical requirements: HERE
It is planned for Thursday, 26 February 2026. More information on the agenda, fee, start time, and how to sign-up, are available in the above link.
UK Updates
MHRA Blog Post
The MHRA published a new blog post: HERE
Some notable updates include:
- The MHRA will soon launch a consultation on the proposal to indefinitely recognize CE Marked medical devices.
- Good progress is being made on the pre-market Statutory Instrument for medical device reform, such as reclassification of IVD devices. The next step is to publish the draft text to the World Trade Organization, and to request industry feedback on anticipated costs to comply with the new legislation.
- Now that the survey on designated standards is closed, the MHRA is planning to update the designated standards list. They expect to roll them out gradually with the first set of updates expected by December 2025.
Switzerland Updates
Export Certificate Guidance & Forms Revised
The updated guidance is available here, and the updated forms are available here.
Changes include:
- Clarification that a product list can only contain one legal manufacturer (except for systems and procedure packs).
- An additional fee will be charged for export certificate orders containing extensive product lists, due to the additional resources required for processing.
