The European Commission is wavering as pressure builds for it to allow initial audits to be performed virtually under the Medical Device Regulation.
Amanda Maxwell, European Regulatory Affairs Editor, Medtech Insight
The medtech industry and the European Commission have reached stalemate when it comes to compliance with the Medical Devices Regulation, delegates heard at the recent Informa Connect MedTech Summit on 12 October.
Stakeholder pressure is growing to persuade the European Commission to overturn its decision not to allow notified body virtual audits for initial audits of medical devices under the MDR.
This concession is particularly vital as the one-year delay to the MDR date of application to 26 May 2021 is not going to offer the sufficient extra time, industry argues, that it urgently needs for its products to be compliant in time.
Notified bodies and industry alike are lobbying hard, and recent statements from the commission appear to leave the door open to this possibility.
While 26 May 2021 is the date of application of the MDR, full compliance is very difficult right now for any manufacturer who has not already completed the initial audit with their notified body, industry argues.
That is because COVID-19, and social distancing and travel restrictions, have made physical audits impossible and so far, the commission is won’t allow initial audits to be carried out virtually under the MDR, with the exception of products needed to fight COVID-19.
It is not just industry that is affected. Notified bodies will find their workload could be pushed further down the line, resulting in major bottlenecks over the next few years if the work is not more evenly spread.
In a bid to persuade the commission to update its guidance, notified bodies are filling in surveys to show the commission and competent authorities how well virtual audits are proceeding. They are demonstrating how robust virtual audits are, and how many times already they are being witnessed by authorities.
While virtual audits are not permitted for initial audits, nor indeed for unannounced audits, they are allowed in other circumstances such as surveillance audits and audits conducted for recertification.
Suzanne Halliday, regulatory director and head of notified body BSI UK, described the virtual audit issue as the number one priority for notified bodies when she addressed the Informa MedTech Summit. She added that the EU notified body industry association, TEAM-NB, is trying to make sure that notified bodies can do virtual audits for products under the EU’s In Vitro Diagnostic Regulation and MDR as well as the current medtech directives.
The European Commission’s Maired Finuncane, project lead and inspector for joint assessments of notified bodies (medical devices), confirmed at the summit that the MDR makes it clear that initial audits must take place in person for products.
But she acknowledged that when the Medical Device Coordination Group (MDCG) drew up its guidance document, MDCG 2020-4, in April 2020 on alternatives to on-site audits, no one foresaw how long the pandemic would last. MT126564
This guidance document generally allows on-site audits, but not in the case of:
A task force within the commission’s Notified
Bodies Operations Group is continually monitoring the market to make sure that there are no medical device shortages, she told the meeting, adding that “up until summer, the feedback did not provide evidence that there would be a shortage of devices on the market.”
But more time has elapsed now, she said, and this is “under review again.”
