We simplify market access for medical devices

European Commission

New MIR form 7.3.1 is published with numerous sections modified. It will be mandatory from November 2025. Key changes include:

• Newly required information on the manufacturer’s awareness date of reportability.
• More stringent use of IMDRF adverse event terminology codes. The use of own codes is only possible until June 2025.
• Fewer mandatory fields.
• Removal of Switzerland and addition of Northern Ireland (XI) as concerned countries.

Swissmedic

Roundtable on Medical Technology (RTMT) meeting slides, and meeting minutes:

• Notification of custom-made devices, in-house devices, and relabelled/repackaged devices will remain via email (i.e. not swissdamed).
• swissdamed: automatic CH-REP transfer will be possible.
• swissdamed: as the Swiss national database, it will be independent of the future development of the MRA.
• By revealing 2/3 nonconforming cases during the PMS activities, Swissmedic is prompting a general awareness push rather than specific product focus, with plans to incorporate detailed product information in future reviews.
• Per Swiss MedTech’s input, MRA-update is not expected to happen before the end of 2027. CH-REP is to be maintained until at least 2028.
• Swiss MedTech summarized the outcome of the meeting held with MedTech Europe and Swissmedic to reduce unnecessary follow-up questions by Swissmedic on vigilance cases
• No further information is available on Swiss MedTech’s question on whether the simplification of CH-REP labelling requirements implemented in the IvDO will be carried over to the MedDO.

Newly published Swiss Guide on new MIR form: 

• From November 2025, the EU MIR form v. 7.3.1 will be mandatory in Switzerland, too.
• Both pdf and xml files should be submitted, or an active pdf file. 
• Section 1.3.1 “Submitter of the report”: [Other, please specify], [CH Rep]
• Section 1.3.3 “Authorised representative” EU REP information should be filled
• Section 1.3.4 “Submitter’s details”: contact details of CH-REP should be filled
• Field 2.5a: [Others: Switzerland]
• Section 3.4h: [Other], [CH]
• Section 4.3.3c: serious incidents should be stated in the “Country of serious incident” row, and included in “EEA+TR+XI” & “World” rows. 

MedTech Europe

Revised EU Regulatory Framework for medical devices

• MTE targets more efficiency on product approval, change notification
• Introduce simplified pathway for breakthrough innovations
• Urge the lifetime risk-based certification 

Swiss Federal Council

The Swiss Federal Council is exploring simplified recognition procedures for US FDA-approved medical devices in Switzerland, in addition to recognition of CE-marked products under EU legislation. 

• Timelines for next steps have not yet been outlined. 
• The government intends to assign the responsibility for simplified verification of products already authorized by the US FDA to private bodies. Qualification criteria for such bodies are not yet published.

Swissmedic

New Guideline on in-house devices published.

• It builds upon MDCG 2023-1, to clarify the requirements for devices that are manufactured and used within healthcare institutions. It describes what entities qualify and what conditions they need to fulfill, including notification of such devices to Swissmedic.
• The guideline is intended for Swiss hospitals, clinical laboratories, and similar institutions and, thus, available in German, French, and Italian.

New market surveillance campaign 2025 to verify Swiss importer’s compliance

• Focus campaign targeting Swiss importers of medical devices and in-vitro diagnostic devices (IVDs), similar to the one conducted in 2023. 

European Commission

Commission seeks input to clarify rules for General Purpose Artificial Intelligence models (GPAIM)

• The guidelines are aimed at clarifying key concepts underlying the provisions in the EU AI Act on GPAI models.

Team NB

A few position papers are published:

Best Practice Guidance for TD under Annex II & III of EU MDR v.3

• 79 pages instead of 47 pages in the last version, various section updates to bring content up to date.
• Addition of common pitfalls observed by NBs.
• Significant rewriting of the Clinical and PMS sections.
• Clarified wording and improved formatting (including table of abbreviations).

Position Paper on European AI Act v.2

• Foreseeable lack of sufficient designated Notified Bodies (NBs) to implement the Regulation at national level
• Pending clear definition of the terms “substantial modification” and “significant  change”, “AI system” (further to the confusing EU Commission guidelines on this topic), and “safety component”.
• Possible duplication of administrative effort for post-market surveillance and vigilance
• Expected to embed fundamental rights principles in the manufacturer’s risk assessment through standards
• Data governance challenges for NBs include: securing GDPR-compliant access to MF’s data and ensuring enough independent, high-quality datasets for testing. 
• A more pragmatic approach to implementing/interpreting AIA is welcome

Position Paper on IVDR Certification Process

• General procedure for submitting an application for IVDR certification.
• Special procedures for each classification are mentioned