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?
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:
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