MDCG 2019-6 Rev5 | MDCG Update on Requirements for Notified Bodies

Revision 5 of MDCG 2019-6 presents important updates on the requirements for Notified Bodies under the MDR and IVDR, reinforcing regulatory compliance and promoting harmonisation within the European Union. It includes clarifications on impartiality and independence, as well as specifications on consultancy, training and experience of personnel involved in conformity assessment.