UE: Nuova Guida sulla differenza tra dispositivi medici e medicinali

 

The EU Medical Device Coordination Group has published a new document: A Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.

The reason for this guidance is a blurred difference between the two legal definitions: “medical devices” and “medicinal products”.

The demarcation between the Regulation (EU) 2017/745 on medical devices (MDR) on the one hand and the Directive 2001/83/EC on the Community code relating to medicinal products for human use (MPD) on the other hand is crucial for the proper implementation of these sets of legislation and their correct interpretation and enforcement.

Several provisions to establish the demarcation between the two legal frameworks have been laid down in the MDR and MPD.

The Guidance provides further explanations and examples clarifying these provisions in order to support the uniform application of the MDR across the EU.

The document starts with the general discussion of the borderline between medical devices and medicinal products, including relevant definitions and examples. Separate chapters are dedicated to herbal products, substance-based devices and medical device and medicinal product combinations.

Borderline products are those where it is not clear from the outset whether they fall under the MDR or the MPD.  As a general rule, a product is regulated either by the MDR or by the MPD but not both. The conformity assessment procedure or the marketing authorisation procedure to be followed prior to placing a given product on the market will therefore be governed either by the MDR or by the MPD. The procedures of both regulatory regimes do not apply cumulatively.

The full text of the Guidance is available QUI.

To find out more about the product compliance for medical devices and the EU CE conformity assessment system, do not hesitate to contact the Product Compliance Institute directly.