Apr 14, 2020

New guidance from the European Commission’s Medical Device Coordination Group (MDCG) temporarily makes allowances for postponed or remote audits of medical device manufacturers necessary for recertification of CE Marking and related requirements.

The guidance covers certifications under the European Medical Devices Directive (MDD), In Vitro Diagnostic Medical Devices Directive (IVDD) and Active Implantable Medical Devices Directive (AIMDD), but may also apply to the upcoming Medical Devices Directive (MDR) and In-vitro Diagnostic Medical Devices Directive (IVDR) depending on the extent of the coronavirus pandemic as well as the final dates of application for the new Regulations.

Under normal circumstances, manufacturers must undergo on-site audits by Notified Bodies in order to maintain their CE Mark certifications per requirements of the Directives; as European healthcare systems scramble to address COVID-19 outbreaks, these audits may be conducted remotely or delayed, provided certain conditions are met.

“This means that certificates can remain in place during situations where on-site audits cannot be performed and this is applicable to all devices, not only COVID-19 related devices,” explains Ronald Boumans, Senior Consultant, Regulatory Affairs at Emergo by UL. “Of course, Notified Bodies must have these procedures in place, and manufacturers must be able to accommodate remote audits.” These exemptions can be made ‘for whole period of duration of the pandemic COVID-19 as declared by the World Health Organization.” It may take several years until the pandemic has officially ended, so there is room for interpretation by Notified Bodies.

Which Notified Body audits qualify for the new allowance?

The MDCG guidance identifies the following audit types conducted by Notified Bodies that may qualify for postponed or remote arrangements:

  • Surveillance audits
  • Audits for CE Mark recertification
  • Audits for change notifications to certified devices
  • Instances where manufacturers enter into new contracts with Notified Bodies

These types of audits are typically linked to the current Directives, as the MDR and IVDR currently only require auditing for initial certification. However, the guidance document also brings COVID-19-related devices within the scope of this guidance document. “However, there is no strict definition for ‘COVID-19 related devices’,” Boumans mentions, “but maybe that is intended to allow for some flexibility as the pandemic evolves.”

However, the temporary guidance does not apply to unannounced audits or special audits requiring on-site assessments. In addition, MDCG recommends that these temporary measures should not generally be used for initial CE Mark certifications, or for those that extend the scope of a CE Mark certification.

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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:

 

Author

  • Stewart Eisenhart

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