Notified bodies report early success with remote audits but challenges remain

Dive Brief:

Remote audits in Europe conducted to enable medtech oversight during the COVID-19 pandemic have been generally successful, according to a survey of 37 notified bodies by a trade group.
Ninety-seven percent of notified bodies said their remote audits were successful, to greater or lesser extents. They cited more efficient use of time and the ease of involving experts in different locations as the main benefits of conducting audits remotely.
However, the survey also identified downsides and challenges to remote audits, with 57% of notified bodies saying they take longer to conduct than on-site assessments with most encountering problems due to poor network connections.

Dive Insight:

ISO guidelines have explicitly addressed remote auditing since 2018 and the technology to facilitate the off-site evaluation of medtech organizations existed for years before that. Yet, the concept was only pushed into the mainstream by restrictions on travel and in-person interaction imposed to curb the spread of the coronavirus pandemic.

Team-NB, the European association of medtech notified bodies, polled its members in October to learn about their experiences with remote audits. One of the respondents said the experience was generally unsuccessful. The other 36 notified bodies said their remote audits were either moderately, generally or very successful.

Less need for travel was the most commonly cited benefit of remote audits, followed by the ease with which experts based in other places can participate and the scope for "innovative improvement of classic audit formats."

Most respondents have used Microsoft Teams to communicate during remote audits, with smaller numbers of organizations relying on Skype, Zoom and other technologies. The technologies have enabled auditors to interview people, review documents and stream video of facilities.

The reliance on technology has caused problems, though. Most notified bodies said poor network connections are a common obstacle. Notified bodies have also faced obstacles related to the limited IT skills of audited organizations, poor image and sound quality, as well as the need to scan documents. The situation is improving but 57% of notified bodies said remote audits take longer. The other 43% of respondents said remote audits take the same amount of time.

Other surveys have found less obvious downsides to remote audits. A survey by consultancy Unity found "missing soft facts" is the biggest challenge of virtual audits. The finding reflects concerns that remote assessments deprive auditors of signals that are more readily picked up when interacting with a person face to face or walking around a facility. Half of respondents to that survey said the quality of audits will fall if they are done virtually. Most respondents said guidance is insufficient.

For now, those concerns may be overridden by the need to audit medtech companies despite the restrictions on in-person interactions, particularly as incoming regulations threaten to overwhelm notified bodies even if they are operating at full capacity.

There are now 17 notified bodies cleared to evaluate products under the Medical Device Regulation and four with In Vitro Diagnostic Regulation designations. Two of the notified bodies, one for each regulation, are in the U.K., which is set to complete its split from the European Union in six weeks.