On 20 November 2024, the Swiss Federal Council voted in favour of certain amendments to the Swiss IVD Ordinance. The changes address various aspects, from adapting the Ordinance to the latest EU IVDR amendments to the indefinite use of simplified labelling for the Swiss market.
Extension of transitional period for IVDs
Following the extension of the transitional period for IVDs in the European Union, Switzerland decided to keep aligning with the EU and mitigate any potential risks of shortages. Consequently, the new EU transitional period for legacy IVDs will start applying in Switzerland from 1 January 2025. The new EU transitional period for IVDR legacy devices – which are recognised in Switzerland as well – are:
- 31 December 2027 for Class D and devices covered by an IVDD CE Certificate
- 31 December 2028 for Class C
- 31 December 2029 for Class B and A sterile
Simplified labelling of IVDs for the Swiss market
The Swiss Federal Council voted in favour of keeping the simplified labelling requirements indefinitely (CH-REP on labels) in order to reduce additional burdens for manufacturers that want to sell in Switzerland. This indefinite provision will also apply from 1 January 2025 and is restricted to devices that are neither intended for self-diagnosis nor designed for use by non-professionals.
Medical devices registration
The obligation to register medical devices and IVDs would apply from 1 July 2026. For this purpose, Swissmedic is developing Swissdamed, the Swiss Database on Medical Devices. Parts of the database would be available for the voluntary registration of certain devices during 2025. Currently, the actor module is the only module available.
Do you have questions on compliance of medical devices and IVDs in Switzerland? Ask here!
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