The European Commission has released a notice regarding remote audits, effectively loosening the rules a bit and allowing notified bodies more flexibility to perform audits during the pandemic.

The result should be a significant help to NBs who are struggling to perform audits required by the MDR. However, NBs must justify the use of remote QMS audits on a case-by-case basis and conduct an on-site visit as soon as possible.

📢 Key Takeaways:

• "Calls for the possibility to take temporary extraordinary measures, including remote audits, related to notified body on-site audits under the medical devices Regulations have been made by industry as well as notified bodies.“\

• “including remote audits, related to assessments performed under the medical devices Directives appears to demonstrate an adequate level of safety and not to compromise the overall reliability of such assessments.“

📚 Document: Commission Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed in the context of quality management system assessment (Text with EEA relevance) 2021/C 8/01

🔍 See the details here : https://bit.ly/3r6bSS0

🔍 Link to PDF (English) : https://bit.ly/3pDlweq