The European Commission’s Medical Device Coordination Group (MDCG) issued a guidance temporarily allowing postponement or remote audits of medical device manufacturers necessary for the re-certification of CE marking and related requirements.
Normally, manufacturers must undergo on-site audits by Notified Bodies to maintain their CE Mark certifications; under the current emergency situation, these audits may be conducted remotely or delayed, provided certain conditions are met.
The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organization. The measures apply to all medical devices, not only COVID-19 related.
Which Notified Body audits qualify for the new allowance?
According to the MDCG guidance, the following audit types conducted by Notified Bodies may be postponed or performed remotely:
- Audits for CE Mark re-certification
- Audits for change notifications to certified devices
- Surveillance audits
- Instances 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).
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