As of 1 February 2026, a revised list of variations according to Articles 21-24 of the Swiss Therapeutic Products Ordinance (TPO) has come into force. This update affects medical device manufacturers and regulatory professionals involved in the Swiss market.
What Changed?
The revised list of variations under Annex 7 of the TPO is a significant update, aiming to clarify and streamline the variation procedure for medical devices. This change impacts manufacturers who need to comply with the new requirements to ensure their products remain authorized for the Swiss market.
Key Updates
- Revised classification of variations
- New requirements for documentation and justification
- Updated timelines for submission and review
Implications for Manufacturers
The revisions to Annex 7 will have several implications for medical device manufacturers:
- Need to reassess their current variation procedures to align with the new requirements
- Possible impact on the validity of existing authorizations if variations are not properly addressed
- Importance of ensuring compliance to avoid any market disruptions
Next Steps
Manufacturers should carefully review the revised list of variations and adjust their procedures accordingly. It is recommended to consult the official Swissmedic guidance for detailed information on the changes and how to comply.
FAQs
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What is the effective date of the revised list of variations?
The revised list of variations is effective as of 1 February 2026.
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How does this update affect existing authorizations?
Existing authorizations may be impacted if variations are not properly addressed according to the new requirements. Manufacturers should review their current procedures to ensure compliance.
Conclusion
The update to Annex 7 represents a significant change in the regulatory landscape for medical devices in Switzerland. Manufacturers must be aware of these changes and take necessary steps to ensure compliance and maintain market access.
Disclaimer
This information is provided for general guidance only and should not be considered as legal advice. Manufacturers are advised to consult the official Swissmedic guidance and seek professional advice where necessary.
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/information/nachfuehrung-anhang-7-amzv-revidierte-liste.html