MedTech Europe is calling for ities to allow notified bodies to conduct virtual audits of medical devices and in vitro diagnostics during the COVID-19 pandemic.
In a position paper published Wednesday, the trade group argued restrictions on travel and access to manufacturing sites are making it impossible for medtech companies to effectively use the one-year delay to the Medical Device Regulation date of application.
MedTech Europe argues the European Commission and member states can clear the bottleneck by using technologies such as smart glasses and webcams to enable notified bodies to see inside facilities without visiting in person.
When the Commission delayed the MDR date of application, it told the industry to "ensure that this additional year is used appropriately and consciously." However, medtech companies can only act on the advice if they can use the additional time to complete conformity assessments under MDR. Conformity assessments typically require notified bodies to visit medtech facilities in person.
The Commission's Medical Device Coordination Group recognized that in-person audits are hard to perform during the pandemic in April, when it published guidance for notified bodies about remote assessments. MDCG designed the guidance to support notified bodies designated under the outgoing regulatory frameworks, but said assessments conducted under MDR and the In Vitro Diagnostic Regulation could benefit from the same flexibility if "the availability of devices is affected by COVID-19 restrictions."
MedTech Europe argues the MDR and IVDR provisions of the guidance are insufficient, noting that "outside of COVID-19 products, there is however, no similar extraordinary guidance that would apply to audits that are supposed to happen under the frame of the two new Regulations." As the trade group sees it, that could lead medtech manufacturers that are ready to be audited under MDR or IVDR to revert to working under the older directives.
The inability to get audited under MDR and IVDR could store up problems for later, for example by creating a surge in demand for in-person audits that overwhelms the system when restrictions on travel are lifted. MedTech Europe also sees a more pressing concern related to the response to COVID-19.
"Several Notified Bodies are meanwhile set-up to certify new devices under the two Regulations, and no longer under the three prior Directives. Unless 'virtual' audits are permitted under the Regulations, there is a high potential that innovative products needed in the EU (e.g., to shield COVID-19 intensive care units from saturation) would not be available on time," MedTech Europe wrote.
Faced with those issues, the trade group is asking ities to permit notified bodies to perform virtual audits under MDR and IVDR during the pandemic. MedTech Europe wants notified bodies to be able to perform virtual initial quality management system audits under MDR and IVDR for new technologies or significant changes to existing devices that "may be considered critical or useful to healthcare systems."
MedTech Europe also wants manufacturers that have already completed initial MDR and IVDR audits to be able to undergo remote surveillance audits. In that situation, the group contends the logic set out by MDCG in its April guidance is relevant.
The proposals are underpinned by a belief that the technology exists to efficiently perform virtual audits. MedTech Europe lists smart glasses, webcams and teleconferences among the technologies that can facilitate the work "as they allow site manufacturer representatives to walk auditors through the manufacturing line."