Specific emergency measures available during COVID-19 crisis
Before utilizing temporary emergency audit options outlined in the MDCG guidance, Notified Bodies should establish documented procedures identifying which of these measures they plan to use, as well as criteria for adopting such procedures. These emergency measures may include:
- Postponing on-site surveillance audits per documented procedures;
- Remote audits, provided information and communication technologies are adequate to support these activities and in line with European legislation regarding information security and data protection;
- Off-site assessment of required documents and records;
- Using international guidance from sources such as the International Accreditation Forum (IAF) in developing alternative auditing processes.
Remote audits may require documents to be shared, web cameras can be used for audits of production lines, etc. It is not recommended to use standard web conferencing tools for this because of cybersecurity issues. However, more sophisticated applications often require more bandwidth, which is at this moment in short supply in some parts of the world. On top of that, designating authorities may request to observe remote audits.
MDCG recommends that Notified Bodies determine whether and when to utilize emergency auditing measures on a case-by-case basis, according to risk-based approaches. Notified Bodies may review existing and previous records of manufacturers they’ve audited in the past, for example, to determine whether remote auditing is a viable option during the COVID-19 health emergency. “Companies that have always gone that extra yard to ensure the best outcomes of audits may now see these efforts pay off in the form of trust by their Notified Body,” Boumans notes.
It is important to add that delayed audits must be performed once travel restrictions have been lifted. This is not the same as the end of the COVID-19 pandemic because within countries, or between them, travel may start up again, while other parts of the world are still locked. This also implies that the lifting of travel restrictions may not immediately result in MDR certification audits in general because other audits must first be performed. It is also not clear what will happen if an audit has been postponed until after the new date of application of the MDR. Will it still be possible to do such audit? And if so, what will happen in case of a finding?
Related European medical device regulatory resources from Emergo by UL:
- Emergency market access for medical devices and IVDs in Europe
- COVID-19 regulatory news and analysis resource center
- European MDR preparation support and resource center
- European CE Marking strategy for medical devices