Q&A requirements related to notified bodies

The Medical Device Coordination Group (MDCG) has published an update to its Q&A related to notified bodies’ requirements under MDR and IVDR, MDCG 2019-6 Rev5 (https://health.ec.europa.eu/document/download/9c9c532f-013a-477c-9378-0a9e714e5549_en?filename=md_mdcg_qa_requirements_notified_bodies_en.pdf). The purpose of the Q&A is to provide guidance to notified bodies concerning, among other things, the obligations that relate to their designation and operation and how these obligations should be fulfilled. Revision 5 to the Q&A follows the approach of recent updates to other MDCG guidance by providing new and expanded definitions, including the difference between consultancy and regulatory guidance, a subject of some debate. The changes introduced by Revision 5 include the addition of questions and answers concerning the operational principles of notified bodies and amplified obligations concerning appropriate personnel qualifications. The section of the Q&A concerning transparency that must exist in relation to the activities of notified bodies has been amplified. New guidance is also provided concerning clinical evaluation and surveillance audits. The Q&A strengthens the procedures concerning verification that technical documentation submitted by legal manufacturers complies with requirements imposed by the Medical Devices Regulation and the in vitro diagnostic medical devices Regulation. It also strengthens post-market surveillance procedures. Changes have also been introduced in Technical Documentation Requirements including a preferred structure for Technical Documents.