The European Commission has responded to pressure from trade groups and authorised notified bodies to carry out remote audits under the incoming medical device (MDR) and in vitro diagnostic (IVDR) regulations.
Although the Commission initially resisted calls to allow remote audits and limited their use to directives and some products essential to COVID-19 response, it has now given notified bodies the go-ahead to utilise virtual assessments in light of continuing pandemic restrictions.
The decision came amid concerns that insisting on on-site MDR and IVDR audits would disrupt supply, as well as evidence that remote audits are efficient.
The Commission said that the “vast majority” of EU member states were in favour of remote audits and added that available evidence regarding virtual assessments “appears to demonstrate an adequate level of safety and not to compromise the overall reliability of such assessments."
The decision does, however, come with caveats. Notified bodies will be required to justify their use of remote audits for quality management systems (QMS) on a case-by-case basis and must conduct an on-site audit as soon as possible.
MedTech Europe Senior Manager for Regulations and Industrial Policy commented: "This is a significant and positive development. The need for virtual QMS audits under the IVDR/MDR is 'supported by the vast majority of the Member States.' It is now of crucial importance that we avoid fragmented approaches amongst EU Member States."
The MDR is due to go into effect in May 2021, having been delayed for a year due to the pandemic, with the IVDR scheduled to come in a year after that in May 2022.