26/27 January 2022
Within the framework of a survey via the EU Commission, Notified Bodies in the medical devices sector were asked about their experiences with "remote audits". The results are now available.
37 Notified Bodies participated in the survey, which was closed at the end of October 2020. 12,860 audit days were carried out as remote audits under consideration of the Medical Devices Directives. In addition, 389 days were carried out with regard to the regulations for products required by Covid-19 or partial audits.
Fortunately, 75% of the audits were rated as successful or very successful. Only one Notified Body gave a negative assessment. This Notified Body, however, had completed less than 20 audit days. Auditors have made the experience that, depending on the number of audits, their learning process with regard to preparation and implementation has also increased significantly. Interestingly, the number of audit findings is roughly comparable to that of on-site audits.
The greatest advantage identified was the considerably reduced travel time. This led to more efficiency. Yet what were the greatest shortcomings? By far, the item "poor internet connection" tops the list.
You can find the results in a position paper of the Team Notified Body Committee.