We simplify market access for medical devices

Swissmedic

New version of information sheet of Incident EOs v3.6

• Updated just to add reference to guidance document – CH Guide MIR

European Commission

Call for applications for EU Reference Lab (EURLs) under Regulation (EU) 2022/2371 on serious cross-border health threats (not to be mistaken with EURLs under the IVDR):

• This call for application concerns laboratories for respiratory viruses for public health purposes, relevant for the implementation of Regulation 2022/2371 or of the national preparedness and response plans.
• Webinars will take place for interested candidates.

Stakeholder feedback report on AI system definitions and prohibited practices public consultations. The EU AI Office opened a public consultation on the 2 first guidelines published under the EU AI Act. The feedback revealed significant confusion and need for further clarification. The EU AI Office will now have to prioritize additional guidance on the following aspects: 

• The stakeholder consultation showed a strong bias towards industry and technical stakeholders, suggesting the consultation might not fully represent those most affected by AI
• A notable geographic concentration of respondents in major EU economies like Germany, Belgium, and France, along with significant input from the US and UK
• Significant concerns were raised about the clarity and scope of the definition of “AI system” in the EU AI Act, where more precise definitions of some terms are needed
• A major concern was the potential for current definitions to inadvertently include traditional software systems
• Regarding prohibited practices, stakeholders expressed particular concern about emotion recognition systems, biometric categorisation, and social scoring practices
• Significant ambiguity was highlighted around what constitutes “manipulation” and “significant harm” in AI systems, specific examples and clearer thresholds are needed
• Privacy and data protection emerged as critical concerns, better alignment between the AI Act (2024) and existing regulations like GDPR (2016) is needed.

A new webpage on AI Literacy – Questions & Answers is being populated to address the most relevant aspects of AI Act Article 4. The Q&As cover definitions, how to approach compliance, how enforcement shall be implemented, and how the EU AI Office approaches AI literacy, along with other useful resources.

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.