Swiss Federal Council Taking Steps to Allow US FDA Medical Devices in Switzerland
30 April 2025
EU Commission Publishes Updated Manufacturer Incident Report (MIR) Form Version 7.3.1
5 May 2025- Europe
- UDI Working Group March 2025 Meeting Minutes
- Master UDI-DI: Contact Lenses
- Master UDI-DI: Spectacle Frames, Lenses, and Reading Spectacles
- UDI in Mergers & Acquisitions (M&A)
- Digital Product Passport (DPP)
- IVD Working Group Nov 2024 Meeting Minutes
- NoBoCap MDR 10-Week Training Course
- MedTech Europe Open Letter on Tariffs
- UK
- IMDRF
Below is an overview of the April 2025 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., Switzerland taking steps to recognize US FDA devices, new EU Harmonized Standards, and more.
Europe
UDI Working Group March 2025 Meeting Minutes
The UDI Working Group published the minutes from their March 2025 meeting: HERE
Some of the topics discussed are included below.
Master UDI-DI: Contact Lenses
- The Commission confirmed that the two-year transition period provided in Commission Delegated Regulation (EU) 2023/2197, would be extended to three years, i.e., applicability starting 9 November 2026.
- The draft amending act is in the final stages of internal scrutiny, and the associated guidance will be amended accordingly.
Master UDI-DI: Spectacle Frames, Lenses, and Reading Spectacles
- The draft Commission Delegated Regulation underwent the internal scrutiny procedure and the contributions received in the public consultation were being reviewed.
- The draft act is under Technical Barriers to Trade (TBT) consultation until 3 May 2025.
- Once adopted, the act will be published in the Official Journal of the EU (OJEU).
- It will then become applicable in 2028, after a transitional period of three years after the entry into force, the same as the amended act for contact lenses.
Master UDI-DI and EUDAMED Registration
- It was noted that the EUDAMED UDI/Devices module will become mandatory before the Master UDI-DI assignment obligation.
- However, the above Commission Delegated Acts allow for manufacturers to voluntarily assign a Master UDI-DI before it becomes mandatory. Further, manufacturers are strongly encouraged to do so.
UDI in Mergers & Acquisitions (M&A)
- The Commission circulated a draft documentation to Competent Authorities on possible requirements for the implementation in EUDAMED workflows for M&As. The Commission requested feedback by 24 March 2025.
- It outlines three scenarios and related EUDAMED requirements:
- Manufacturer X relocates to another country and becomes manufacturer Y
- Manufacturer Y entirely acquires manufacturer X
- Manufacturer Y acquires manufacturer X’s product line(s)
- The Commission stressed that M&A changes in EUDAMED need to be clearly visible and they will analyze the implementation of such functionality.
Digital Product Passport (DPP)
- A CEN/TC 225 representative raised a query regarding Digital Product Passports (DPP) for UDI.
- The Commission advised they will further analyze the question with participation of Competent Authorities and stakeholder experts. They will then develop a common understanding on the relationship between DPP and MDR/IVDR requirements.
IVD Working Group Nov 2024 Meeting Minutes
The IVD Working Group published the minutes (and stakeholder presentations) from their November 2024 meeting: HERE
Some of the topics discussed are included below.
IVDR implementation
- Stakeholders reported concerns about product discontinuation
- Concerns about the administrative burden, with 50% of the time required for conformity assessment being spent on pre- and post-certification administration according to their latest survey results
- Timelines for notified body designations are decreasing, as the process becomes more streamlined and new tools are implemented
- Industry stakeholders raised the need to address sampling of IVD technical files as a priority, as the work is mostly focused on medical devices currently.
Q&A on Performance Studies
- The consultation of the IVD Working Group and stakeholders resulted in a large number of comments that will need time to be processed.
- Many of the comments relate to combined studies, in-house devices, and performance studies on already CE marked devices.
- The taskforce will revise the draft Q&A with a view to publishing the guidance document in 2025.
Task Force on Health Institutions
- Discussions between authorities on their understanding and application of the definitions were ongoing.
- The task force covered parts of the definition such as the concepts of organisation, primary purpose, patient care and promotion of public health, and examples of organisations that would or would not be considered as health institutions in most Member States.
- For example, public and private hospitals are likely to meet the definition of a health institution in most member states, while contract research organisations (CROs) and laboratories that provide human diagnostics to sponsors of clinical trials or to CROs likely will not.
Q&A on Distance Sales
- The task force produced a draft Q&A document on distance sales. The first draft consisted of 41 Q&As, e.g., to clarify a common understanding of the term ‘offered’ in the phrase “a device offered by means of information society services”.
- In the context of the MDR/IVDR Article 6, a distance sale refers to the sale of a product or service where there is no face-to-face contact between the supplier and the buyer. This includes online purchases, catalog orders, or sales through TV shopping, among others. An ‘information society service’ can encompass both the physical purchase of a product online, as well as services delivered remotely.
- The IVD Working Group and stakeholder consultation are foreseen for 2025 (aim to circulate before end of Q1 2025).
NoBoCap MDR 10-Week Training Course
Registration is now open for NoBoCap’s 10-week online MDR technical documentation training course: HERE
NoBoCap, which stands for Notified Body Increased Capacity, is co-funded by the European Union under the EU4Health programme.
Training Details:
- It is a 10-week, 100-hour online course on constructing an MDR compliant Technical File and Clinical Evaluation Report
- Designed for professionals in medical device manufacturing, regulatory affairs, auditing, and clinical evaluation
- Earn 5 Continuing Professional Development Credits (CPDs), plus a post-graduate certificate accredited by the University of Medicine, Pharmacy, Science and Technology “G.E. Palade” of Târgu Mureș
- Start Date: 19 May 2025
- Registration Deadline: 9 May 2025
MedTech Europe Open Letter on Tariffs
MedTech Europe, together with other EU associations, published an open letter to EU Commission President Ursula von der Leyen: HERE
In it, they note that 90% of the 37,000 medical technology companies are Small and Medium-Sized Enterprises (SMEs), employee 880,000 people across Europe, and “are essential to save and improve people’s lives each and every day”.
They therefore “urgently call for a direct dialogue with you [Ursula von der Leyen] to address this impending crisis”. And urges “in the strongest possible terms to protect public health, by promoting an extension of the Zero-for-Zero proposal to all medical technologies, and to the essential components needed to produce them.”
“The threat of tariffs also comes at a time when Europe’s medical technology sector is already experiencing shortages, an innovation drain, and the risk of SMEs closing business due to European regulatory frameworks – which are excessively costly, time-consuming and unpredictable when compared to medical technology regulatory pathways in other jurisdictions. For example, 1 in 2 healthcare professionals in Europe are already reporting issues with availability of medical devices and 30-40% of large manufacturers have started launching their innovations in other jurisdictions. Tariffs will only further exacerbate these substantial challenges which are already facing the companies who supply Europe with medical technologies.
Moreover, tariffs increase production and distribution costs. Most medical technologies reach hospitals, laboratories or other health institutions, via multi-year agreements with minimal price flexibility. Since price increases cannot be easily mitigated by manufacturers – and particularly by SMEs – increased operating costs from tariffs could easily result in closures, the ceding of innovation to foreign competitors and, ultimately, decreased availability of medical solutions for patients, healthcare professionals and health systems.”
UK
Team Approved Body on Upcoming UK PMS Deadline
Team Approved Body (Team AB) recently posted a reminder regarding to the upcoming PMS deadline in the UK: HERE
Team AB advised that:
- Their “PMS working group has been working closely with the MHRA to develop guidance on the Approved Body aspects of PSUR reviews, which is part of the comprehensive guidance suite released by the MHRA.”
- A BSI webinar was held in March 2025 regarding the new PMS requirements.
- A poll in the webinar revealed that many manufacturers are not fully prepared for these changes: only 25% of attendees had a plan for implementing the new PMS requirements, 50% needed more information to help prepare, and 25% did not understand the impact of the new legislation or was hearing news about it for the first time.
Manufacturers are encouraged to review the regulation and associated guidance as soon as possible to ensure they are ready for the 16 June 2025 deadline.
Free resources available from Casus to help you prepare:
New MHRA Blog Post
The MHRA published a new entry in its blog: HERE
Some items of note include:
- The UK Government highlighted the MHRA’s AI Airlock program in their Regulation Action Plan. It encourages regulators to find a balance between safety, while also allowing for innovation and growth.
- The MHRA is working on phase two of their AI Airlock plan, as recently mentioned in this blog. More to be published in the coming months.
- The MHRA received feedback from partners regarding its PMS Guidance published in January. The MHRA is reviewing the feedback and will update the guidance, as needed. However, most likely no significant changes will be made, only amendments for clarity.
- Meanwhile, manufacturers should continue using the current guidance as published.
- A Statutory Instrument
has been laid in Parliament to retain four pieces of Assimilated EU law until they are formally replaced with UK legislation:
- Commission Decision 2002/364 on the common technical specifications for in vitro diagnostic medical devices
- Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices
- Regulation (EU) No 722/2012 concerning particular requirements for medical devices manufactured utilising tissues of animal origin
- Regulation (EU) No 920/2013 on the designation and the supervision of approved bodies
Upcoming Publications Expected:
- Response to the International Reliance (“routes to market”) consultation
- A draft of the UK’s new Pre-Market Requirements Statutory Instrument
will be published by the World Trade Organization.
- Per the MHRA’s Roadmap of Future regulations, this is anticipated within the next 1-2 months (by mid-2025).
IMDRF
IMDRF 27th Meeting (Tokyo, Japan)
The IMDRF published the meeting outcome statement and presentations from the 10-14 March 2025 Meetings: HERE
Highlights from the meetings include:
- There was an IMDRF/Industry Joint Workshop to discuss the benefits and challenges of expanding Regulatory Reliance
- The AI Working Group is working on a ‘Technical Framework for AI Lifecycle Management’. The document outline has been created, and two subgroups are drafting subsections of the document. The first draft submission is planned for Winter 2025/Spring 2026.
- The QMS Working Group aims to complete a new draft of the GHTF Guidance on the ‘Control of Products and Services Obtained for Suppliers’ by the end of May 2025.
- The SaMD Working Group is targeting a draft ‘Essential Principles and Content of Predetermined Change Control Plans’ (PCCPs) for late 2025.
- Australian TGA Updates:
- Draft UDI regulations are being reviewed and are expected to start Q1/Q2 2025. Further, that 1) guidance will be released, and 2) the Australian UDI Database (AusUDID) will go-live once the regulations take effect.
- The regulation will be amended to allow for eIFUs for medical devices, with conditions, e.g., a paper IFU must be available free of charge within a reasonable timeframe if requested, and paper IFUs must still be provided for single use/disposable consumer products, self-tests and point of care tests, emergency-use consumer devices, etc.
- New regulatory reliance pathways: 1) Class IIa via MDSAP Certification + evidence of exemption from US FDA 510(k) regulation, and 2) Class III via MDSAP + US FDA 510(k) clearance.
IMDRF Competent Authority Report Exchange Criteria & Form
The IMDRF revised the National Competent Authority Report Exchange Criteria and Report Form: HERE
The document’s intended audience are competent authorities, and the changes are minor, such as updating to reference the latest IMDRF Adverse Event Reporting (AER) Terms, Terminology, and Codes.
