NEW – Guidance on borderline between medical devices and medicinal products

A significant and useful new guidance document on the borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices has just been endorsed by the Medical Device Coordination Group (MDCG 2022-5 ).

The MDCG is a regulatory body of industry experts and advisors who provide guidance and advice to the European Commission and all other stakeholders. MDCG’s aim and purpose is to assist the Commission in ensuring that medical device coordination is consistent and that implementation is harmonised across all member states. MDCG aim to ensure the safe and effective use of medical devices in Europe under the scope of medical devices Regulations (EU) 2017/745 and 2017/746.

This latest document to be endorsed by the MDCG (MDCG 2022-5) provides a central point of guidance on the borderline between medicines and medical devices. It is essential to understand this demarcation so that the correct legislation may be understood and implemented. This latest document provides explanations beyond those already provided in the legislation and also provides examples clarifying these provisions. This helps to ensure the uniform application of the MDR across the EU.

‘MDCG 2022-5’ has been elaborated by a working group including experts from Member States’ competent authorities, the Commission services, European Medicines Agency as well as a wide range of stakeholders prior to MDCG endorsement.


JensonR+ are very pleased to see this latest guidance document which is much needed by manufacturers and stakeholders. Misinterpretations are always possible and the clarifications provided in any MDCG endorsed guidance should always be followed alongside the applicable device regulations. The given interpretations in such guidance documents should always be followed as ‘expected best practice’.

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