EC clears path for remote audits by notified bodies
Remote audits will be an option during the pandemic for some European medical device and in vitro diagnostic manufacturers, following an announcement from the European Commission (EC).The temporary step takes into account the “exceptional and unforeseen circumstances caused by the COVID-19 crisis,” according a notice issued by the EC on Monday. Both industry and notified bodies had felt hamstrung by the complete stall in inspections caused by the coronavirus pandemic. (RELATED: MDCG clarifies remote audit expectations for notified bodies, Regulatory Focus 04 December 2020)
The inability to complete audits had been additionally anxiety-provoking given looming deadlines for the EU’s medical device regulation (MDR) and in vitro diagnostic regulation (IVDR), coming in May 2021 and 2022, respectively. (RELATED: Experts share advice, concerns and expectations for IVDR, Regulatory Focus 03 November 2020)
Notified bodies’ ability to complete the audits required as part of the conformity assessment process have been “significantly affected” during the pandemic, noted EC. The Commission said that it had taken a “cumulative set of circumstances” into consideration, weighing the pandemic’s effects, the need to keep medical devices and IVDs available and out of shortage, and the underlying goals of on-site audits.
Regarding the last point, EC said that “extraordinary measures” such as remote audits appear to demonstrate “an adequate level of safety and not to compromise the overall reliability of such assessments.” A case-by-case analysis is still needed that takes into consideration such factors as travel restrictions and national pandemic-related measures that may preclude in-person audits. A remote audit can be considered in circumstances where the inability to perform an on-site audit “could prevent granting access or ensuring continued supply of devices to the market,” wrote EC.
Remote audits are limited to the period of time when such measures are “strictly necessary,” and this is not a blanket okay to supplant on-site with remote audits, noted EC. A remote audit should only be considered when needed for availability of safe devices that perform as intended, and when COVID-19 is blocking the path to on-site audits.
Notified bodies should use a risk-based approach and ensure they have carefully reviewed all technical documentation provided by the manufacturer.
Specifics of how remote audits are to be carried out are left to the member states, and notified bodies are to inform EC about their inspection methods and the rationale for their use.
European Commission