Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements
The MDGC (Medical Device Coordination Group) has published guidance in order to ensure timely compliance with MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Medical Regulation). The study calls on manufacturers, and the bodies that help regulate them, to increase transparency in regards to the timeline for conformity assessments and increase their public availability. It recommends publishing said information on a widely available source, such as the internet or the entity’s website. It also encourages greater discussion in regards to manufacturers and regulators, to ensure a smoother conformity assessment.
It should be reminded that this document is not a European Commission document, and thus is not legally binding. It is merely a document endorsed by the MDCG.
The MDGC (Medical Device Coordination Group) is composed of representatives of all Member States, and is chaired by a representative of the European Commission.
