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Amendment of Swiss In Vitro Diagnostic Medical Device Ordinance (IvDO)
The Swiss IvDO amendment aligns Swiss in vitro diagnostic rules with EU IVDR, extends transition timelines, and confirms the product registration deadline. A 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
See more 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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