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Guidance on ‘virtual audits’ published by Commission

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Medical Device Coordination Group (MDCG) has now published a guidance document relating to how Notified Bodies will be allowed to continue conducting audits under the medical device directives during the coronavirus crisis, which has seen many countries restrict travel and issue ‘stay at home’ orders, although the document states that “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 document is titled ‘Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions‘ has been given the reference MDCG 2020-4, and “takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation”.

The scope of the guidance covers:

  • surveillance audits under the medical devices Directives,
  • audits conducted for re-certification purposes under the medical devices Directives,
  • 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).