MDCG 2025-10: New MDR/IVDR Guidance on Post-market Surveillance (PMS)
30 December 2025
MDR/IVDR Reform Proposal: Open Feedback Period 7 January 2026 – 4 March 2026
7 January 2026Below is an overview of the December 2025 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., the new deadline for MIR Form 7.3.1 and the Commission’s MDR/IVDR reform proposal.
Europe
MDCG 2025-9 on Breakthrough Devices
MDCG 2025-9 is available: HERE
This new guidance document is intended to address the process and regulatory considerations for qualifying, assessing, and certifying breakthrough devices (BtX). Both medical devices (BtMD) and in vitro diagnostic medical devices (BtIVD) can qualify.
What is a Breakthrough Device (BtX)?
It is a device that offers a novel diagnostic or therapeutic option, which addresses an unmet medical need for a particular patient population with serious and life-threatening diseases or conditions. The novelty aspect is as compared to the current state-of-the-art.
These products can obviously have significant patient benefit. However, they must still be assessed for safety and efficacy. MDCG 2025-9 aims to help facilitate safe innovation by providing information on a streamlined pathway for CE marking, as well as considerations for the clinical or performance evaluation.
The guidance was also developed so that status as a BtMD or BtIVD can be designated early during device development. This allows the device manufacturer to utilize the support system and benefits available, including funding mechanisms. See Section 4 of the guidance for BtX criteria, including how novel the product is expected to be to qualify as a BtX.
Draft Legislation to Revise Notified Body Requirements
The draft implementing regulation is available: HERE
Among other changes, the Commission proposes that Notified Bodies must:
- Provide itemized cost estimates upfront, including potential additional costs and travel expenses. Any unforeseen additional costs must be communicated promptly with justification.
- Comply with maximum timelines: 30 days for application processing, 120 days for QMS audits, 90 days for product assessment, and 15 days for final certification decisions. These timelines must be agreed with manufacturers and stated in quotations.
- Limit the number and duration of suspensions (e.g., while awaiting expert opinions), which must be agreed in writing.
- Publish annual reports by April 30 of each year showing assessment durations and cost ranges from the previous year, increasing transparency (except where fewer than 5 assessments were completed).
Team NB published a Position Paper in response. In it, they acknowledge that specific timelines can improve predictability and speed. However, they disagree with the timelines proposed.
| Commission Proposal | Team-NB Counter Proposal | Team-NB Rationale |
|---|---|---|
| Application Review: 30 days | Application Review: 30 days | No change requested from draft implementing act. |
| QMS Audit: 120 days | QMS Audit: 120 days | No change requested from draft implementing act. |
| Technical Documentation Assessment: 90 days | Technical Documentation Assessment: 150 days | 90 days would prevent training new staff, make it harder to use external experts, and increase costs. |
| Final Decision: 15 days, no clock-stops | Final Decision: 25 days, with one clock-stop allowed | Too restrictive given limited qualified staff. |
| Recertification Timelines: 60 days for NB review | Recertification Timelines: 100 days | Doesn’t account for device complexity or manufacturers with multiple simultaneous certificate expirations. Team-NB also wants manufacturers to request recertification at least 1-year before expiration. |
| New Implementing Act Transition Timelines: 3 months | New Implementing Act Transition Timelines: 12 months | Team-NB also requests 6 months for quotation process changes. |
Other issues raised by Team-NB include:
- Strongly opposed to publicly publishing annual assessment durations and cost ranges (no surprise). Instead, they propose they should be audited by Notified Body designated authorities.
- NBs lack resources/expertise to verify financial statements, to assess if a company qualifies as an SME
- Impossible to estimate travel costs accurately at quotation time
- Request to implement a ±20% threshold before requiring manufacturer notification of cost changes (rather than notifying for any deviation)
The draft act was published on the WTO site on 22 December 2025. Interested parties have until 20 February 2026 to submit their comments.
MDCG 2025-7 Updated: Timelines for Master UDI-DI
MDCG 2025-7, rev.1 is available: HERE
It was updated to add the EUDAMED applicability dates, as compared to the dates that assignment of Master UDI-DI becomes mandatory:
- EUDAMED Device Registration: 28 May 2026 (with six-month transition period for devices already on the market)
- Master UDI-DI for Contact Lenses: 9 November 2026
- Master UDI-DI for Spectacle Frames, Spectacle Lenses, and Ready-to-Wear Reading Spectacles: 1 November 2028
As noted above, EUDAMED device registration becomes mandatory before the requirement for Master UDI-DI. The purpose of Master UDI-DI is to help reduce redundant EUDAMED device entries. Therefore, the Commission strongly recommends manufacturers to voluntarily comply with Master UDI-DI early, when entering their data into EUDAMED.
Team NB on SARS-CoV-2 Test CE Marking
The Position Paper is available: HERE
In March 2025 SARS-CoV-2 devices were down-classified, from Class D (highest risk) to Class C (layperson use) or B (professional use only).
Team NB’s position paper outlines the practical next steps for manufacturers impacted by this reclassification:
- Existing Class D CE certs
- Manufacturer updates technical documentation and then submits a change notification to NB to make appropriate corrections
- NB reviews change notification and revises certification structure, reissues cert as class B or C
- Applications under review
- NB to try to finalize conformity assessment per agreed schedule; will either issue class D cert and the request an immediate change notification or will try to apply the down-classification during the review
- Applications submitted and accepted but not yet under review
- Change notification occurs before review begins; manufacturer must update technical documentation and QMS (if applicable) before review
- Applications submitted but not accepted or reviewed, no planning activities yet
- NB will halt activities, and manufacturer must submit new or updated application
New EU Reference Laboratories Designated
The Commission adopted an implementing act designating four EU reference laboratories (EURLs): HERE
The newly designated EU Reference Laboratories (EURLs) cover the following category of Class D IVD devices:
- Parasites
- Blood grouping markers
The EURLs are expected to begin their tasks related to IVDR conformity assessment on 1 May 2026.
United Kingdom
MHRA Regulatory Advice Meetings
The MHRA recently implemented ‘Regulatory Advice’ meetings: HERE
These are structured meetings, providing regulatory advice to medical device manufacturers. These meetings are not intended to provide feedback on future regulations, request support for/form a UK Approved Body, or provide general guidance on existing guidance. Nor will the MHRA provide consultancy, e.g., provide information about a specific device’s design or development.
The above link outlines:
- How to request a meeting
- The fee (£987)
- Structure of the meeting (one hour, and should start with a short presentation given by the meeting requestor)
- What occurs after (e.g., send your meeting notes within 15 working days so the MHRA can review them for accuracy, and outline any corrections or changes, if needed)
MHRA Blog Post
The MHRA published a new blog post 22 December 2025: HERE
While short, it notes that:
- They intend to publish the new Pre-Market Statutory Instrument to the WTO early 2026, a precursor to laying the Statutory Instrument in Parliament
- They are drafting the consultation on indefinite recognition of CE marking, which will also be published early 2026
IVD Roadmap
The MHRA published a new IVD roadmap: HERE
It provides an update on the following plans:
- Regulatory Support for Innovative IVD Technology
- Regulatory Science and Research
- Pandemic Preparedness and Resilience
Conformity Assessment Routes Flowchart Updated
The MHRA updated its conformity assessment routes flowchart: HERE
This document outlines the conformity assessment processes for companies seeking UKCA Marking.
While UKCA Marking isn’t required (the MHRA accepts CE Marking), some companies choose it because UK classification rules still follow MDD/IVDD. This allows self-certification for certain devices that would require a Notified Body under MDR/IVDR. For example, IVDD “other” devices, Class I reusable surgical instruments, and some software devices.
For more information please read: Is there any advantage to UKCA Marking early?
Call for Evidence for Regulation of AI in Healthcare
The overview is available: HERE
The purpose is to obtain feedback on:
- Whether the UK’s framework for regulating AI in healthcare is sufficient
- How the UK’s regulatory framework may need to be improved to ensure fast access to safe and effective AI medical devices
- Approaches to checking safety once AI medical devices are in use
- How responsibility and liability are managed between different parties involved in the deployment of AI medical devices.
The questionnaire is available until Monday 2 February 2026.
Switzerland
Swissmedic MIR Guidance Updated
The updated guidance document is available: HERE
Among other changes, it was updated to clarify:
- What level of minimum information is required in the Manufacturer Incident Report (MIR) form.
- The number of MIR forms required based on the volume of incidents, e.g., one incident with several devices vs one device with several known incidents.
- Adds a new section (5.3) on content-related requirements.
- Note that the new MIR Form 7.3.1 will become mandatory in Switzerland the same time it becomes mandatory in Europe.
‘swissdamed’ Deadlines Will Not Change to Match EUDAMED
Swissmedic reconfirmed that swissdamed deadlines will not change to align with EUDAMED deadlines: HERE
EUDAMED will become mandatory starting 28 May 2026, followed by a six-month transition period.
Swissmedic confirm that this does not impact the deadline for swissdamed:
- Actor registration module became mandatory 6 August 2024.
- UDI/Device registration module becomes mandatory 1 July 2026, followed by a six-month transition period for devices that were already on the market.
IMDRF Strategic Plan 2026-2030
The IMDRF published its 2026-2030 strategic plan: HERE
It outlines the organization’s priorities for the next 5 years, such as:
- Convert GHTF documents to updated IMDRF documents
- Continue to publish new technical documents on innovative technologies
- Identify and engage with new stakeholders
- Enhance opportunities for all stakeholders to engage with and contribute to IMDRF activities
- Enhance IMDRF trainings
