The Regulatory Affairs Professional Society (RAPS) reports that the Commission of the European Union (EU) is taking steps to permit the limited use of remote audits for some medical devices during the current global pandemic.
According to an article posted to the RAPS website in mid-January, the Commission’s plan is in response to the extended delay in conducting physical audits of medical device manufacturing facilities during the pandemic, and the looming deadline associated with the EU’s Medical Device Regulation (MDR), set for May 2021, and the deadline for the In-Vitro Diagnostic Regulation (IVDR), set for one year later in May 2022.
The article cites a Commission statement that remote audits appear to demonstrate “an adequate level of safety and not to compromise the overall reliability of such assessments.” However, the use of remote audits is limited only to situations where such measures are “strictly necessary.”
Notified Bodies are also expected to use a risk-based approach to ensure a thorough and complete audit. Finally, Notified Bodies who use remote audits must keep the Commission informed about the rationale for the use of remote audits and their inspection methods.
