This guidance is intended to cover 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).
Although this guidance applies to the medical device Directives only, 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.