Under certain circumstances, remote audits should now also be possible. The guideline will be effective immediately and will be valid for the duration of the COVID 19 pandemic according to the classification by the World Health Organisation (WHO).
The following audits for conformity assessments of medical devices are covered by the guideline:
- 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 following temporary extraordinary measures and arrangements may be conducted as an alternative to on-site audits:
- Postponement of on-site surveillance audits under the Directives in line with documented procedures of the notified body for force majeure.
- On-site audits may be replaced by remote audits using the most advanced available Information and Communication Technologies as appropriate in accordance with legislation on information security and data protection.
- Assessment of all relevant and required documents/records off-site by the notified body.
- To take into account existing recent results from MDSAP audits (or other appropriate audits) in lieu of Directive audits, where available
- To consider published international guidance such as those issued by the International Accreditation Forum (IAF) e.g. on how to use information and communication technologies and for alternative auditing methods in extraordinary circumstances
New approaches will be followed during the pandemic here as well. It needs to be shown to what extent modern communication technologies for conducting audits continue to be possible in the future.
EC: Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions