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Swissmedic

Swissmedic has published an updated version of their Swiss guide for manufacturer’s MIR. This new version introduces significant content and structural changes on how to complete the new MIR form v. 7.3.1.

• Manufacturers are expected to complete all fields in the form, even if not marked mandatory, unless there is a transparent reason for omission.
• “One device, one MIR”: if an incident involves multiple devices and the primary cause is unclear, a separate MIR must be submitted for each device. If the responsible device is known, associated devices must be listed in section 2.6.
• “One incident, one MIR”: manufacturers must submit one MIR per incident. The use of date ranges to cover multiple incidents involving the same device in a single report is prohibited.
• Section 5 on Swissmedic requirements has been expanded and restructured into three distinct subsections: General rules (section 5.1), formal requirements (section 5.2), and content-related requirements (section 5.3).
• The new section 5.3, includes detailed instructions on specific MIR fields.
• A new Section 6 on Transition period has been added, clarifying that the new MIR 7.3.1 form will only become mandatory in Switzerland once the EU transition period has expired.

European Commission

MDCG 2025-8 Guidance on implementation of the Master UDI-DI was published. 

• Master UDI-DI Assignment Timeline: The mandatory application for assigning Master UDI-DI to these devices’ (spectacle frames, spectacle lenses, and ready-to-wear reading spectacles) labelling is 1 November 2028.
• Detailed guidance on the UDI components of assigning the Master UDI-DI for these devices

EUDAMED Mandatory Use Postponement: The EU Commission’s Decision (EU) 2025/2371 on the functionality and the fulfilment of the functional specifications of EUDAMED has been published in the OJEU of 27 November 2025. It officially declares the functionality of EUDAMED’s first 4 modules (Actor, Vigilance, Clinical Investigation/Performance Studies, and Certificates).

In accordance with the transitional provisions in Reg. (EU) 2024/1860, these 4 modules will become mandatory 6 months after this publication, i.e. as from 28 May 2026. 

Swissmedic has not yet reacted to this postponement, however, it is expected that the mandatory use of swissdamed’s UDI  module will be postponed accordingly. 

Swissmedic

The swissdamed Playground is now available. This platform allows economic operators to practice registering users, submitting data, and familiarizing themselves with the system before the mandatory go-live. A User Guide for the Playground has also been published.

Swissmedic

Updated Information Sheet on Export Certificates (v.3.10 of 11-Nov-2025). The changes include:

• Clarification of the section 4.3 (requesting company), 4.6.2 (certificates for legacy devices),  and 7 (fees).
• Removal devitalized products.

EU Commission

On 19 November 2025, the EU Commission published the Digital Omnibus package that encompasses targeted simplification measures on the implementation of certain EU AI Act’s provisions. Among them, a proposal to postpone the application date for high-risk AI systems per Annex I from August 2027 to August 2028.

Team-NB

New template agreement form to be used by incoming and outgoing Notified Bodies for the transfer of EU MDR formal application and of appropriate surveillance of legacy devices, specifying the terms of the transfer in respect of legacy devices covered by Directives certificates.