The European Union has announced that it will temporarily allow remote audits of medical devices and in vitro diagnostics under the new regulations (MDR IVDR), set to go into effect on May 2021 and 2022 respectively.
In a document published Monday, the European Commission agreed with industry and notified bodies that the ongoing COVID-19 pandemic has made in-person audits at manufacturers’ facilities difficult if not impossible.
Remote audits appear “to demonstrate an adequate level of safety and not to compromise the overall reliability of such assessments,” the EC wrote.
But the decision doesn’t specify how to perform remote audits or change the MDR IVDR legislation that requires all medical devices and IV diagnostics to comply with the new regulations. It’s a temporary measure that will last only until on-site audits are possible again and it leaves the specific approach to such audits up to each of the 27 member states. Notified bodies must work with the competent authorities in each state to determine the conduct of audits in that state, which could complicate matters for medtech manufacturers seeking approval for a device in more than one state. Notified bodies must also keep the commission informed of their methods and their justification for using them.
Still, the move was a welcome one.
“This is a significant and positive development,” wrote Merlin Rietschel, senior manager of regulations and industrial police for MedTech Europe, on LinkedIn. “The need for virtual QMS audits under the IVDR/MDR is ‘supported by the vast majority of the Member States,'” Rietschel added, quoting the EC document. “It is now of crucial importance that we avoid fragmented approaches amongst EU Member States.”
Europe’s largest notified body, BSI, had been pushing for the commission to allow remote audits because the pandemic has caused a backlog, according to Gary Slack, senior VP of medical device business for the Amsterdam-based company.
“We wholeheartedly support it,” Slack said in an interview with Medical Design & Outsourcing. Customers have also reacted positively to the news, but Slack cautioned that they should read the EC document carefully.
Team-NB, an alliance of notified bodies, was also lobbying in favor of the remote audit option but had not posted a specific comment on the EC decision. “Team-NB task force is working on harmonised views on harmonised risk-based approach regarding Commission notice published today,” the organization said on its website.