October 12, 2023

The Latest Version of the Manual on Borderline and Classification under MDR and IVDR is Here!

The latest updates in the world of medical device regulations in Europe.

The European Commission (EC), in collaboration with the Medical Device Coordination Group (MDCG), has released an updated version of the “Manual on Borderline and Classification for Medical Devices” under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The root canal irrigation solution, temperature sensors embedded in orthopedic devices for compliance tracking, system intended to produce sclerosing foam, n-butyl-2-cyanoacrylate based adhesives, and custom-made cranial implant are just a few products of the new entries.

This updated manual is a valuable resource for manufacturers, regulatory professionals, and stakeholders in the medical device industry. It provides clear guidance on the classification of medical devices under MDR and IVDR, helping ensure compliance with the latest regulations.

For more detailed information, you can access the full manual on the European Commission’s website below:


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