The EU Medical Device Coordination Group (MDCG) has once again revised MDCG Guidance 2019-6 on “Questions and answers: Requirements relating to notified bodies”. It is now in its 4th edition which provides an update on the question posed in III.6 “What is the meaning of the term “employed” in MDR Article 36(1)/IVDR Article 32(1)?”.
This section states that personnel shall be understood as those who perform key functions at the Notified Body such as the responsibility to establish qualification criteria and authorising other personnel to perform specific conformity assessment activities. Furthermore, this includes personnel who have responsibility for final reviews and decision-making on certifications. Such personnel cannot be external or subcontracted.
Read the full revised version here.