We simplify market access for medical devices

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

European Commission

New Harmonised Standards under the EU MDR have been adopted via the Implementing Decision 2025/679 – HS for sterilization of medical devices

• EN 556-1:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices
• EN 556-2:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 2: Requirements for aseptically processed medical devices’

New Harmonised Standards under the IVDR have been adopted via the Implementing Decision 2025/681 – HS for medical gloves for single use, sterilization of medical devices and patient handling equipment used in ambulances

• EN 455-1:2020+A2:2024 Medical gloves for single use – Part 1: Requirements and testing for freedom of holes
• EN 455-2:2024 Medical gloves for single use – Part 2: Requirements and testing for physical properties
• EN 556-1:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices
• EN 556-2:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 2: Requirements for aseptically processed medical devices
• EN 1865-2:2024 Patient handling equipment used in ambulances – Part 2: Power assisted stretcher
• EN 1865-6:2024 Patient handling equipment used in ambulances – Part 6: Powered chairs’.

Publication of the AI Continent Action Plan. It covers the following aspects:

• A large-scale AI computing infrastructure is being developed
• EU internal market for data and data labs within EU AI factories will increase access to high-quality data
• Commission will launch apply AI strategy, e.g. integrate AI into healthcare sector
• Bring skilled experts/workers to EU, help workers upskill/reskill
• Simplifying the implementation of the AIA

Swissmedic

A few new versions of forms are published:

• Orders for export certificates for medical devices
• Orders for export certificates for medical devices subject to old legislation as well as DEVIT products and IVD