Fifth revision to MDCG 2019-6 Guidance document released

What is new?

The fifth revision to MDCG 2019-6 splits two questions into sub-questions, updates the answers to five existing questions and introduces a new Q&A.

Compared to the previous version, more clarification is given with regards to the time period that notified personnel carrying out conformity assessment tasks need to take into account to avoid potential conflicts of interest with clients that they were previously associated with. The current revision also elaborates on what would be considered ‘consultancy’ by notified bodies, why conformity assessments can only be started after an application has been lodged, and what should be understood as ‘structured dialogue’ between a manufacturer and its notified body. Further, updated answers are provided relating to allocating notified body resources, acceptable time framefor surveillance audits and requirements for re-certification.

The new question addresses the leverage of evidence that was provided with previous applications by the manufacturer to that notified body. This should be addressed as part of the structural dialogue and may also apply to devices previously certified under the medical device directives.

What does it mean to you?

MDCG 2019-6 Rev.5 is important for notified bodies as well as MD and IVD manufacturers: it provides guidance on organisational, resource, process and quality management system requirements for notified bodies. Establishing a good understanding of these requirements is important for MD/IVD manufacturers when selecting, contracting and interacting with notified bodies under MDR or IVDR.

Navigate Regulatory Complexity with Confidence

Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.