Thanks to Ton Pennings from CEpartner4U, our European medical business development professionals are brought up to speed again. He spoke to EuroDev about the latest developments regarding the new regulations for medical devices in Europe.
Although the new regulations came into force on May 25th, 2017 (the date of application for MDR is May 26th and for IVDR May 26th 2022), we recommend our North American principals to start the implementation as soon as possible. This way, they can stay ahead of the game.
Due to the already stricter law enforcement at the moment, the number of European notified bodies was downsized by almost 50%. This is causing long queues at notified bodies.
Please check with your NB when they will be notified for doing assessments under the MDR/IVDR.
Key changes in the new regulations include:
- The existing 3 directives (MDD, AIMD, IVDD) will become 2 regulations (MDR and IVDR);
- Changes in the following definitions: “MDR”, “IVDR”, “medical device”, “manufacturers and economic operators”, “importer and distributor” and “clinical performance and benefit’’;
- All medical device manufacturers working under quality management principles;
- The authorized representative will have more responsibility;
- Manufacturers should have at least one qualified person available within their organization who is responsible for regulatory compliance;
- Change in obligations for importers and distributors;
- New identification system to facilitate identification and traceability (UDI);
- New Eudamed configuration;
- Conducting clinical investigations more often;
- Informing users consistently about risks;
- Manufacturers will need to have a Post market surveillance report (PMRS) and Periodic safety update report (PSUR);
- Own brand labelling (OBL/PL) will not exist anymore;
- More risk rules (MDR: 5 new risk rules, 24 new criteria, some devices get a higher classification, IVDR: complete overhaul in device risk classification, new classification of IVD’s by risk and 4 regulatory classes (A.B.C.D) based on 7 rules).