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)
This statement relates to the above Commission Notice (2021/C 8/01) published on 8 January 2021 relating to MDR (EU) 2017/745 and IVDR (EU) 2017/746 audits undertaken during the current acute COVID-19 pandemic restrictions.
BSI Notified Body 2797 wholeheartedly welcomes this communication, which recognises the acute COVID-19 pandemic needs and allows potential for fully remote audits under the regulations in these challenging times. However, it’s important to note this is not a change to the underlying regulations.
The communication clearly requires EU Member States (Competent Authorities) to further define and finalize their approach, also to notify the Commission by submitting information as to their implementation. As a result, further stakeholder discussion is required prior to implementing a practical approach, and BSI is engaging with our Competent Authority to agree and define the approach to be taken. We appreciate the acute urgency and will communicate over the next couple of weeks the practical steps to be taken.
We are of the firm view that the best way to protect patients and to support manufacturers is a consistent approach across the 27-Member States. Therefore BSI NB 2797 is, in parallel, engaging with Team NB to try to agree with Member State Competent Authorities a consistent set of guidelines, ensuring a uniform approach in all jurisdictions.
Gary Slack Dr Suzie Halliday
Senior Vice President Medical Devices Head Notified Body
BSI Group BSI The Netherlands BV