MDR & IVDR: Update to Manual on borderline classification!

The Medical Devices Coordination Group (MDCG) released in December 2022 a new update to their manual on borderline and classification for medical devices under MDR and in vitro diagnostic devices under IVDR. As the September version was analyzed in our previous MDlaw post, the changes under the updated manual are the following:

  • Other medical devices borderlines.
    • New example: Medical calculators with the characteristics defined in the manual are considered medical devices (Rule 11, at least Class IIa);
    • New example: Needle Counters with the characteristics defined in the manual are not considered medical devices;

It is worth mentioning that the Manual will be further updated. The MDCG Group will provide additional examples and information through the Helsinki Procedure in future publications.

To know more about the Helsinki Procedure, you can consult Exchange of information between medical device competent authorities on borderline and classification cases.

This document provides added value to the information already stated in previous classification guidance documents, such as the MDCG guidance on classification of medical devices, the MDCG guidance on borderline between medical devices and medicinal products, the MDCG Guidance on classification rules for in vitro diagnostic devices under IVDR, among others.

You can find this manual and many more documents in our Library of documents – Classification.

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