MDCG 2021-24 Rev.1 Guidance on Medical Device Classification

Content

The Medical Device Coordination Group (MDCG) has published Revision 1 of MDCG 2021‑24, the guidance dedicated to the classification of medical devices under Regulation (EU) 2017/745 (MDR).

This update aims to further support consistent and harmonized application of the classification rules across the EU, by providing additional clarifications and practical adjustments expected by manufacturers and notified bodies.

Key updates include:

Clarification of the concept of invasiveness for implantable devices: the term “surgical” has been replaced by “clinical”
Terminology alignment in the application of the classification rules (“device” replaced by “product”)
Structural adjustments to better reflect certain classification rules
Updates to several key rules (in particular Rules 2, 8, 9, 10, 12, 16 and 22), with additional notes and examples

This revision represents a reference document for securing classification decisions and anticipating their regulatory implications under the MDR.

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