The pandemic COVID-19 has resulted in various restrictions to countries around the globe. It has affected the ability of notified bodies to conduct mandatory on-site audits under the medical device legislation.
The World Health Organization has published guidance on temporary extraordinary measures, which are related to medical devices, Notified Body audits during times of COVID-19. It allows continued availability of safe medical devices to the market and prevents any risk of medical device shortage.
When does it apply?
- During 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)
Arrangements related to on-site audits
Notified bodies may introduce following temporary alternative extraordinary measures for on-site conformity assessment audits, that have been impacted by the restrictions of COVID-19:
- 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 the 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
Audits that are not covered
Initial certification audits or audits that extends the four stated appliances under the Directives are not applied to follow the temporary extraordinary measures. However, “notified bodies may apply these extraordinary measures on a case-by-case basis for such audits in cases where devices are considered relevant to ensure medical care, especially if clinically necessary during the period of COVID-19 restrictions”.
For further described information, regarding MDCG guidance, follow the link: https://ec.europa.eu/docsroom/documents/40705