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: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/anpassung-verordnung-ivd.html
If you have any questions, get in touch: info@eumediq.eu