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Swissmedic IvDO Amendment 2025: Key Changes for IVD Compliance
The amendment to the Swiss IvDO restores equivalence with EU IVDR, extends transitional provisions, and confirms when product registration becomes mandatory. A concise summary of the changes.
New year starts with amendment of Swiss In Vitro Diagnostic Medical Device Ordinance (IvDO) in order to restore euqivalence to EU IVDR (EU 2017/746).
It includes
Extension of tranisitional provisions for medical device certification
Permanent simplification of mandatory labelling for devices dispensed by professionals
Product registration obligation enters into force at 1st July 2026
For more info see here.
KEY TAKEAWAY
The amendment to the Swiss In Vitro Diagnostic Medical Device Ordinance (IvDO) restores equivalence with EU IVDR (EU 2017/746).
It extends transitional provisions for medical device certification, permanently simplifies mandatory labelling for devices dispensed by professionals, and brings the product registration obligation into force on 1 July 2026.
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