This guidance covers the following audits notified bodies are requested to carry out as part of medical devices conformity assessments:

  • 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).

The guidance does not apply to unannounced audits or to special audits which require onsite assessment. In addition, initial certification audits or audits to extend the scope of certification under the directives should not be performed using these temporary extraordinary measures.

The guidance opens the possibility to postpone onsite surveillance audits under the directives and to replace them with remote audits as long as both the notified body and manufacturer can ensure information and data remain secure.

What does this mean to you?

Carefully read the MDCG 2020-4 Guidance document and asses if your notified body audit may be eligible for an alternative route and contact your notified body to discuss the further details. 

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.

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