UK MHRA to Implement Annual Medical Device Registration Fees Starting April 2026
28 September 2025
UK MHRA’s Annual Registration Fee: New Guidance and Registration Webpages Updated
20 October 2025Below is an overview of the September 2025 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., UK to introduce annual registration fees, and MDCG Working Group releases draft Trend Report form and guidance.
European Commission
Update to the Borderline and Classification Manual
Background
This manual provides guidance on whether a product falls under the MDR or the IVDR, or if it is outside these frameworks (for example, classified as a medicinal product, cosmetic, or biocide). It is updated regularly to clarify difficult cases, often where there is uncertainty, or conflicting interpretations across EU Member States. The last update was September 2023 (version 3).
Products Assessed in Version 4 (September 2025)
The updated manual is available: HERE
The new decisions cover five specific product types:
- Dual action cream with menthol and capsaicin: Determination of whether such creams fall under MDR as medical devices or remain in another category.
- Red blood cell additive solutions containing adenine: Clarification on whether these should be considered IVDs, medical devices, or medicinal products.
- Lactose tablets for vaginal use: Classification guidance on whether these count as medical devices, given their intended local effect.
- Mobile sterile air system: Assessment of whether air sterilization systems qualify as medical devices.
- Qualification of microabrasion dental stain removers: Clarification on whether such dental cleaning products fall under MDR.
Master UDI Requirements for Frames, Lenses, and Reading Glasses
Background
The MDR’s UDI system uses two parts: the UDI-DI and the UDI-PI. For optical products, assigning a unique UDI-DI to every small variant creates too many EUDAMED entries.
The Commission therefore introduced Master UDI-DI, which lets manufacturers group variants that share defined design parameter combinations under one UDI-DI, reducing administrative burden.
Update
Commission Delegated Regulation (EU) 2025/1920 amends Annex VI Part C of MDR to introduce Master UDI-DI rules for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles: HERE
It was published in the Official Journal on 23 September 2025, making its:
- entry into force date 13 October 2025 (20 days after publication), and
- application date 1 November 2028 (first day of the month following 3 years after entry into force).
While the application date is not until 2028, manufacturers are strongly encouraged to implement Master UDI-DI early and voluntarily. This avoids the need to upload thousands of redundant UDI-DIs into EUDAMED, which is expected to become mandatory before Regulation 2025/1920’s formal application date.
Team Notified Body
IVDR Documentation Best Practices Updated
Background
The purpose of this document is to help manufacturers understand Notified Body expectations on IVDR technical documentation, and in turn, reduce deficiencies and shorten the review time.
Update
Team-NB released Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of IVDR, Version 2: HERE
Below are examples of newly added information:
- Performance Evaluation Report: a justification for the chosen approach to gather clinical evidence needs to be provided.
- Software: links to Team-NB’s Position Paper on software qualifications.
- Stability: the study protocol needs to represent routine use, automated and manual processing needs to be addressed separately
- Analytical Sensitivity: should provide a description of specimen type including surrogate samples, matrix, analyte levels and how the levels were established. If a surrogate sample is used, manufacturers need to provide a commutability study.
- Declaration of Conformity: should include the device intended purpose if this is necessary for the identification of the device and if it cannot be clearly and unambiguously concluded from the name of the device.
EU Regulations Discussion Day on 7 Nov 2025
Team-NB will host the 1st EU Regulations Discussion Day on 7 November 2025, in Brussels. More information is available: HERE
The event brings together manufacturers, regulators, and Notified Bodies for discussions on the future regulatory framework for the medical devices sector.
Program highlights include:
- Best Practice Guidance on MDR/IVDR Technical Documentation
- MDR/IVDR implementation challenges
- EUDAMED update from the European Commission
- Panel sessions with NB perspectives and opportunities for exchange
Details:
- Location: Sofitel Brussels Europe
- Time: 09:00–17:30 CET
- Fee: €250 (SMEs and NB members), €400 (other organisations)
IMDRF
Implementation Report – Edition 2
The IMDRF’s Implementation Report, first published on 9 September 2024, outlines the ‘Implementation Levels’ of IMDRF technical documents in each participating country.
The report helps industry identify where international requirements diverge. For example, it shows which countries have adopted the UDI guidance fully, which made national adjustments, and which have not implemented it at all.
Edition 2 of the Implementation Report was published in September 2025 to reflect changes over the past year: HERE
Below is an example of the changes between September 2024 and September 2025.
28th MC Meeting Sapporo, Japan
The IMDRF published the meeting outcome statement and presentations from the 15–19 September 2025 meetings: HERE
Some highlights from the meetings include:
- Artificial Intelligence / Machine Learning (AI/ML) Working Group: continued development of an AI Lifecycle document, addressing considerations for manufacturers across the full device lifetime. A draft is targeted for public consultation after the first Management Committee meeting in 2026.
- SaMD Working Group: submitted draft on Essential Principles and Content of Predetermined Change Control Plans (PCCPs) to the Management Committee. PCCPs are intended to support iterative software updates while maintaining oversight. Finalization and consultation are expected in late 2025/early 2026.
- Clinical Evidence for IVDs Working Group: drafting a new IMDRF document that consolidates and updates GHTF N6 and N7 guidance on clinical evidence. It includes new sections on software IVDs and companion diagnostics, and a draft is expected to go to public consultation at the first Management Committee meeting in 2026.
