In brief
With a communication dated 11 January 2021, the European Commission has recognized the possibility for Notified Bodies to perform remote audits on medical devices aimed at verifying compliance with applicable safety and effectiveness and obtaining the CE marking.
- This decision addresses the requests from Member States, Notified Bodies and medical device companies who informed the Commission that travel and quarantine restrictions imposed in response to the COVID-19 pandemic have significantly affected Notified Bodies’ ability to conduct on-site audits on the premises, which could raise the risk of shortages of vital devices.
- In this respect, the Commission nevertheless pointed out that the failure of Notified Bodies to carry out on-site audits should be limited in time, identified and justified on a case-by-case basis and not go beyond what is required to ensure continuous availability of safe and performant devices, when concrete obstacles to complete conformity assessments on-site have been created by COVID-19 circumstances.
Lastly, the Commission recalled the obligation of Member States authorities to monitor Notified Bodies established on their territory to ensure that they comply with the requirements laid down in the applicable legislation and stressed the fact that, in case of non-compliance, national authorities shall suspend, restrict, or fully or partially withdraw the designation, depending on the seriousness of the failure to fulfill those obligations.
