Audit Alternatives of Notified Bodies in Covid-19 Times

Recommendation

4/5 October 2023

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Due to the Covid-19 pandemic, on-site audits by Notified Bodies are partly only possible to a limited extent or not at all. What are the alternatives? A guideline of the Medical Device Coordination Group (MDCG) provides information on this.

The guideline with only six pages addresses the following topics:

• Surveillance audits in accordance with the medical device directives 
• Re-Certification Audits 
• Audits in the context of changes 
• Initial Certification

It refers to the currently still valid medical device directives of the EU, but can, if necessary, also be applied under the Medical Device regulation. The guideline explicitly states that the proposed options do not apply to unannounced audits, very individual audits (e.g. to confirm specific corrective actions on site), and extension audits. However, even in these cases, alternative measures in the sense of urgent health protection or market supply remain possible.

The criteria, when "alternative measures" are applied (e.g. in case of "force majeure") and how they are handled, will be described by Notified Bodies in specification documents. The decision to use alternative measures should be made on a case-by-case basis and on the basis of a risk-based approach. The audit plan and report should clearly identify the alternative measures applied.

The following alternative measures are possible: 

• Postponement of the audit on site 
• "Remote Audits" 
• Evaluation of documents and reports outside the company to be audited 
• Inclusion of MDSAP audit results (or other appropriate audits) 
• Inclusion of international guidelines, e.g. of the International Accreditation Forum (IAF) on alternative audit methods

"Remote Audits" should not only consider technical aspects but also the protection of intellectual property, data protection and cybersecurity.  A separate chapter describes the decisions that lead to certification. However, the guideline is not legally binding. It remains valid until the WHO has declared the Covid-19 pandemic to be over.
 
You can find the Guidance on temporary extraordinary measures related to medical devices Notified Body audits during Covid-19 quarantine orders and travel restrictions on the EU Commission website.