Notified body audits during the pandemic: New MDCG guidance

Regulatory NewsRegulatory News | 08 April 2020 |  By 

The Medical Device Coordination Group (MDCG) on Wednesday issued guidance to help notified bodies perform audits during the pandemic, including, under certain circumstances, remote audits.

The 5-page guidance deals strictly with surveillance audits under the medical devices directives, audits conducted for recertification purposes under the directives, in cases where a manufacturer submits a change notification to a notified body that would typically require an on-site audit or verification and in cases where a manufacturer terminates (voluntarily or involuntarily) its contract with a notified body and enters into a contract with another notified body.

The guidance opens the possibility for not only postponing onsite surveillance audits under the directives but replacing them with remote audits as long as both the notified body and manufacturer can ensure information and data remain secure.

“For remote audits, both the notified body and the manufacturer must have the required information and communication technologies or tools available and established (e.g. web conferences with document sharing, use of web cams for audits of production lines). Confidentiality of intellectual property aspects shall be safeguarded. Notified bodies should clearly document and communicate any such requirements for their audits with their auditees, along with the required documentation to be shared before and within such audits,” the guidance says.

Notified body audit reports also should clearly indicate that the audit was conducted remotely and the audits should cover all surveillance tasks that can be verified remotely, including an off-site review of all documents that would normally be assessed onsite, the MDCG says.

“Subsequent to a successful remote audit a notified body may re-issue the certification with the condition that such audits should be followed up by an on-site verification audit at the next available opportunity to verify the elements that could not be assessed remotely (the timeline for the on-site verification audit should be justified by the notified body). At the request of the notified body, the manufacturer may provide the notified body with records (e.g. product release documentation) on an ongoing or regular basis. If the re-certification remote audit is unsuccessful, the certification should be suspended or should expire as appropriate,” the guidance adds.

The MDCG also mentions that notified bodies should account for existing recent results from audits under the Medical Device Single Audit Program (MDSAP) “in lieu of Directive audits, where available,” and they should “consider published international guidance such as those issued by the International Accreditation Forum (IAF) e.g. on how to use information and communication technologies and for alternative auditing methods in extraordinary circumstances.”

But the guidance notes that it may not be appropriate to use these temporary measures for manufacturers with “a history of a high number and/or critical non-compliances related to production/operational control.”

The MDCG also says the guidance does not apply to unannounced audits or to special audits which require onsite assessment, such as the verification of implementation of specific corrective actions which can only be assessed onsite.

In general, the guidance says that 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,” the guidance says.

Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions


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