The Medical Device Coordination Group has just released MDCG 2021-24 Rev.1, the updated guidance on the classification of medical devices under the EU MDR (Regulation (EU) 2017/745).
At Asphalion, we’ve reviewed the key changes you need to be aware of:
- Implantable devices (§3.1.4) – The term ‘surgical’ has been replaced by ‘clinical’ in the definition of implantable devices, broadening the scope to encompass both surgical and non-surgical procedures.
- Classification rules scope (§3.2) – The word ‘device’ has been replaced by ‘product’, reinforcing that classification rules apply to all products in scope of the MDR, including Annex XVI products.
- Rule 8 (Long-term & implantable devices) – Table updated and seven new practical notes added, providing much-needed clarification on implant classification, spinal column contact, accessories to AIMDs and more.
- Rule 9 (Active therapeutic devices) – Restructured for better alignment with the rule text, plus updated practical issues of classification.
- Rules 10, 12, 16 & 22 – Tables updated with clearer examples and improved practical guidance.
- Rule 22 (Closed-loop systems) – A new note clarifying the classification of AED pads/electrodes placed on the market independently.
Correct classification is the foundation of your regulatory strategy, it determines your conformity assessment route, clinical evidence requirements, post-market surveillance obligations and more. These updates may require you to revisit your existing classification rationale.
If you need support reviewing the impact of these changes on your device portfolio, our regulatory experts are here to help.
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