MDCG Guidance on Notified Bodies, Distributors, and Importers
What is MDCG?
The MDCG (Medical Device Coordination Group) is an organization established to bring together regulatory personnel from EU member states to make determinations on the classification of new medical devices and to address devices that fall into gray areas. The MDCG was newly established in conjunction with the implementation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). The MDCG is composed of representatives from each member state, with one knowledgeable member and one alternate appointed to represent each country.
The primary opinions and advice that the MDCG provides to the European Commission include the following: determining the classification status of medical devices, developing common specifications and guidance documents, designating notified bodies (NBs) in coordination with the Designating Authority and the European Commission, supporting competent authorities in their market surveillance activities, providing advice on the European Databank, the Electronic System on Registration, and the Unique Device Identification (UDI) system, and providing recommendations on the designation of expert panels and expert laboratories.
Guidance on Notified Bodies, Distributors, and Importers
On August 20, 2021, the MDCG issued an important guidance document titled “Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.” This guidance provides comprehensive direction to notified bodies, distributors, and importers regarding certification activities conducted under Article 16(4) of the EU Medical Devices Regulation (MDR) No. 2017/745 and the In Vitro Diagnostic Regulation (IVDR) No. 2017/746.
This guidance is important for companies within the EU that engage distributors and importers to perform relabeling and repackaging of medical devices.
The MDR and IVDR require that distributors and importers who perform relabeling (re-labeling) or repackaging (re-packaging) of medical devices establish a Quality Management System (QMS) (MDR/IVDR Article 16(3)). Furthermore, the QMS established by distributors and importers is subject to certification review by notified bodies (MDR/IVDR Article 16(4)).
Notified bodies that perform QMS certification of distributors and importers must be designated for the types of medical devices (device categories) that are the subject of relabeling and repackaging activities for the relevant devices.
The MDCG 2021-23 guidance is a comprehensive guidance document that specifies the scope of matters that must be covered in the QMS established by distributors and importers who perform relabeling and repackaging of medical devices, the requirements regarding audits by notified bodies and the review of change notifications, and the matters to be taken into consideration during evaluation for QMS certification.
