When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation.
It addresses alternative solutions to carrying out on-site audits by notified bodies under the medical devices directives and under circumstances the MDR and IVDR under specific circumstances, which includes the possibility to perform remote audits under certain conditions.
“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.”
The guidance covers the following audits:
- surveillance audits under the medical devices Directives,
- audits conducted for re-certification purposes under the medical devices
- 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).
IVDR is covered ‘in principle’! This is the first time I see something positive in guidance in relation to the IVDR. IVD companies, make this count and use this time to not give up on or start conformity assessment with the few notified bodies there are for the IVDR before these are completely crowded. This will also help fast track clearance for self-tests for COVID-19 under the IVDD and IVDR covered COIVD-19 tests. Hurrah!
Not covered audits
Generally initial certification audits or audits to extend the scope of certification under the Directives should not be performed using these temporary extraordinary measures. However, notified bodies may apply these extraordinary measures on a case-by-case basis for such audits in cases where devices are considered relevant to ensure medical care, especially if clinically necessary during the period of COVID-19 restrictions.
Within the confines of audits covered and not covered the notified bodies have wide discretion on how to work, provided that the measures are covered by appropriate procedures. The guidance gives a number of examples of temporary alternative extraordinary measures and arrangements to on-site audits. The procedures should be carefully assessed and documented by notified bodies on a case-by-case basis and performed using a risk-based approach. This risk-based approach should be based on a review of the notified body’s
“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).”
More detail coming
The guidances mentions that the MDCG NBO working group is tasked with the development of guidance to define the operational implementation details of this guidance document. More detail will no doubt follow.