The Medical Device Coordination Group just released a guidance document on Notified Body audits during the ongoing COVID-19 pandemic. It takes immediate effect and is valid for the period of the duration of the pandemic as declared by the WHO. It covers alternative solutions to carrying out on-site audits by notified bodies under the medical devices directives MDR and also the IVDR under specific circumstances, which includes the possibility to perform remote audits.
The guidance covers the following types of audits and situations:
- surveillance audits under the medical devices Directives,
- audits conducted for re-certification purposes under the medical devices Directives,
- in cases where a manufacturer submits a change notification to a notified body that would typically require on-site audit or verification,
- in cases where a manufacturer terminates (voluntarily or involuntarily) its contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device(s).
Note this is not a mistake, the above only covers the MDD, not the MDR! It goes on to state:
“Although this guidance applies to the medical device Directives only, for Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) in the event that the availability of devices is affected by COVID-19 restrictions the principles in this guidance may apply.”
Although many audits (for instance, initial certification audits and audits to extend the scope of certification under the Directives) are not covered, the guidance gives wide discretion to Notified Bodies on how to work, provided the extraordinary measures are covered by appropriate procedures. Notified Bodies are to apply a risk-based approach on a case-by-case basis. It states the following:
“In order to assess which alternative extraordinary measure (…) is most appropriate, the notified body should review their files relating to the status and operations of the manufacturer related to the audit in question, for example the activities conducted at the site to be audited, its quality management system, and its level of compliance from previous audits. Following this review, a risk analysis should be made as to whether or not the audit could be performed with alternative measures. Where a postponement cannot be justified, the notified body should assess which alternative extraordinary measure should be performed (e.g. remote audit; off-site document review; conference calls with relevant personnel of the manufacturer).”
The guidance concludes with stating that the MDCG NBO working group is tasked with the development of guidance to define the operational implementation details of this guidance document.