EU MDCG have published the 5th Revision of the Q&A: : Requirements relating to notified bodies – MDCG 2019-6 Rev 5
Although applicable to EU Notified bodies, it is useful to see what the EU Competent authorities are asking notified bodies to require, and allows companies to prepare supporting evidence accordingly. The latest update includes improved content on structured dialogue, re-certification, and leveraging evidence.
Guidance – MDCG endorsed documents and other guidance – European Commission
