As Bern and Brussels were unable to agree on a Mutual Recognition Agreement to recognise the MDR (Medical Device Regulation), we have been going our separate ways since June of this year, as is already known.
The Swiss Medical Devices Ordinance (MedDO; SR 812.213) sets out requirements and responsibilities for those involved in the supply chain of medical devices. Details were published by the Swiss authority Swissmedic in an information sheet on 27 September.
One consequence of the regulatory separation is the provision of authorised representatives in the other territory.
Swiss manufacturers now come from a third country and must appoint an EU REP (European Authorised Representative) . Conversely, non-Swiss economic operators are now obliged to appoint corresponding CH-REP , because if the manufacturer of a medical device is not based in Switzerland, their products may only be placed on the market after an authorised person based in Switzerland has been mandated (Art. 51 para. 1 MedDO).
This also applies to manufacturers based in the European Union. We would also like to point out the transitional periods at this point:
- for Class III devices, Class IIb implantable devices and active implantable medical devices: until 31 December 2021;
- for non-implantable class IIb devices and class IIa devices: until 31 March 2022
- for class I devices: until 31 July 2022.
BEO BERLIN bietet seit ihrer Gründung den EU-REP Service, damals unter MDD (Medical Device Directive) und heute unter MDR für Hersteller*innen aus Drittstaaten an.
As of 01 November 2021, BEO BERLIN will now also offer a solution for the provision of a CH-REP.
If you need a representative office for Switzerland or have questions about the CH-REP, please contact usWe will be happy to advise you!
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