BEO BERLIN has been offering the EU-REP service, then under MDD (Medical Device Directive) and now under MDR (Medical Device Regulation) für Hersteller*innen aus Drittstaaten an. Ab dem 01. November 2021 wird BEO BERLIN nun auch eine Lösung für die Bereitstellung eines CH-REP anbieten.
As Bern and Brussels were unable to agree on a Mutual Recognition Agreement to recognise the MDR, 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-REPs, because if the manufacturer of a serious everyday safety problems 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.
At this point, the company draws attention to transitional periods:
- 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.
The company will be available for personal consultations from 15-18 November 2021 at MEDICA at the Berlin Partner joint stand in Hall 15 / Stand 22.
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