EU Commission allows temporary remote QMS audits under MDR and IVDR
Today, the EU Commission has published a notice in the OJ that notified bodies might temporarily perform QMS audits remotely in exceptional cases and on a case-by-case basis. Notified bodies can thus deviate from the IVDR and MDR requirement that QMS audits take place on-site.
Member States, notified bodies, industry and other stakeholders have insisted that travel and quarantine restrictions have significantly affected the ability of notified bodies to carry out-site audits at manufacturers' sites. As the inability of notified bodies to carry out on-site audits may increase the risk of a shortage of vital devices, the European Commission responds to requests for exceptional temporary measures, such as remote audits.
The European Commission allows these temporary extraordinary measures given the exceptional and unforeseen circumstances caused by the COVID-19 crisis, the need to ensure continuous access to safe and effective medical devices and medical in vitro diagnostics and the fact that remote audits performed under the Directives seem to show an adequate level of safety.
While reminding the Member States of their obligations to monitor notified bodies established in their territory, this notice gives them the possibility to allow notified bodies to carry out remote audits on a temporary basis. Notified bodies are required to identify and justify remote audits on a case-by-case basis, and the individual circumstances should be documented and duly substantiated. Member States are invited to inform the EU Commission of measures taken by individual notified bodies (including information to justify such measures).
We advise you to discuss your options for a remote audit with your notified body as soon as possible and use the already available MDCG documents (MDCG 2020-4 and MDCG 2020-17) on remote audits to prepare accordingly. A remote audit requires thorough preparation; this includes:
- Scheduling mock remote audits;
- Testing the connection and sound quality beforehand;
- Ensuring that all audit participants are familiar with the required hard- and software;
- Clarifying legal aspects in advance (consider data security and privacy issues in connection with sharing of documents, recordings, use of the camera, etc.);
- If employees participate from their home office: ensuring that the connection, infrastructure etc. are sufficient;
- Ensuring the IT department is ready to deal with possible technical problems (e.g. connection issues).
If you have questions regarding audit preparation (remote or on-site), our team of experts is always ready to help.