New harmonised standards

In co-operation with relevant federal authorities, and upon agreement with SECO, switec (the Swiss information center for technical rules) keeps indexes of technical standards that are referred to in technical regulations.

Latest news: Negotiations over an Institutional Framework Agreement between Switzerland and the EU were terminated in May 2021. Would you like to know more about the topic? Click here…

Lists of technical standards relating to medical devices under previous law

Medical devices that were placed on the market in conformity with previous law and/or comply with the transitional provisions are still subject to the old technical standards. The transitional provisions and deadlines are defined in Chapter 11 Section 2 of the MedDO and in Chapter 10 Section 2 of the IvDO, as well as in Art. 120 of the EU-MDR and Art. 110 of the EU-IVDR.

You can find additional information in the FAQ's from Swissmedic.

It is important for distributors to know which versions are recognised and applicable, and what periods of transition apply. In order to preserve legal conformity, it is indispensable for distributors to consult the updated indexes of harmonised standards!

All standards are available for ordering in the SNV online shop.