The European Commission attempts to further clarify its expectations on IVD medical devices related to SARS-CoV-2 and its manufacturers.
In January 2022, the Medical Device Coordination Group (MDCG) published MDCG 2022-1 titled “Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices”. As the title says, the document targets mainly at manufacturers of COVID-19 IVD tests outside the EU.
MDCG 2022-1 lists among others the obligation of these manufacturers to appoint an EU Authorised Representative, but also broaches the topics of when to involve a notified body, what are the translation requirements for labels and IFU and where important guidance can be found.
Finally, the guidance explains what should be regarded in terms of transition to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
Please let us know if you would like to have a copy of MDCG 2022-1 for your reference.
Source: European Commission