Swiss Third Country Status for IVDs

The Mutual Recognition Agreement (MRA) between Switzerland end the European Union was not renewed to include the IVD Regulation 2017/746. Thus, as of the Date of Application (DoA) of the IVDR, 26 May 2022, Switzerland will be considered a third country under the IVDR for both IVDR compliant devices as well as all IVDD 98/79/EC compliant devices making use of the transitional provisions, even if they have a valid Notified Body certificate.

All Swiss manufacturers and distributors of IVDs must realise that as of 26 May 2022 they will have to comply with the requirements of a third country for all IVDs (IVDR and IVDD). This essentially involves the appointment of a European Authorized Representative for all IVDs exported to the EU from Switzerland, and a Swiss Authorized Representative for all IVDs imported into Switzerland.

On May 4th, 2022, the Swiss authorities adopted the new Regulation on In-vitro Diagnostics (IvDO), which is largely based on the IVDR. The new IvDO will enter into force on 26 May 2022. 

As of 26/05/2022 the IVDD 98/79/EC will be repealed and only the IVDR 2017/746 will be in force. Several devices may make use of the transitional provisions stated in IVDR Article 110 (3 and 4), but these devices must be considered as being regulated under the IVDR from the date of application onwards and no longer the IVDD. That means that as of 26/05/2022 Switzerland will become a third country for all IVD devices. In article 86, the IvDO provides manufactures with some time to appoint a Swiss authorised representative (CH-REP) and to adapt device labelling. The dates by which the legal Manufacturer will have to mandate in writing the Swiss entity that will act as the CH-REP on the manufacturer’s behalf in relation to specified tasks in accordance with IvDO, are:

  • Class D devices: 31 December 2022 
  • Class B and C devices: 31 March 2023 
  • Class A: 31 July 2023

What does this mean to you?

If you are a Swiss based IVD manufacturer you should now be ready to meet these new third country requirements, including the designation of a European authorised representative such as Qarad EC-REP BV. If you are based outside of Switzerland and wish to continue placing IVDs on the Swiss market, you should set-up an agreement with a Swiss authorised representative such as Qarad Suisse S.A.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.