Bowing under pressure from frustrated medical device manufacturers and Notified Bodies, the European Union announced that it would allow audits to be conducted remotely. Throughout 2020, calls to allow remote auditing for medical devices grew louder from healthcare industry experts. In June, the Trade group MedTech Europe published a report outlining the need for Medical Device Regulation (MDR) audits to be conducted remotely in order to handle the mounting workload caused by the pandemic. Team N-B, an association that represents Notified Bodies, sounded the alarm in December that soon-to-expire device certificates threatened to create product shortages in Europe.
Citing “exceptional and unforeseen circumstances caused by the COVID-19 crisis,” the European Commission said it will allow virtual audits on a case-by-case basis. Audits can be conducted remotely only if Notified Bodies can show a “concrete need” keeping them from visiting the site in person. Notified Bodies must also commit to facilitating traditional on-site visits as soon as possible.
Initially, the commission only allowed audits to be conducted remotely for directives and products with a direct link to COVID-19, but it changed its stance out of concern that the lack of on-site audits would significantly disrupt medical device supplies and services in Europe. While the Commission said that the “vast majority” of Member States support the transition to remote auditing, there is a possibility that acceptance of virtual audits will shift depending on the country.
The announcement comes at a crucial time, just four months before the MDR is slated to take effect in Europe. While the prospect of addressing the growing backlog of audits virtually could assist orthopedic device manufacturers, many questions remain about the impending MDR and how to stay compliant. To ensure their products remain on the market in Europe, it’s recommended that medical device companies remain in close contact with their Notified Body.
Patrick McGuire is an ORTHOWORLD Contributor.