Ambitious Reform Of The Medical Devices Regulatory Framework

Author:Ms Florence Verhoestraete and Christel Brion
Profession:NautaDutilh
 
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The medical devices sector covers a wide range of products, from simple bandages to highly sophisticated devices such as pacemakers, as well as contact lenses, prostheses, medical equipment for hospital use, etc. This sector is extremely innovative, especially in Europe, and generates around EUR 95 billion annually (Eucomed figures for the EU, Norway and Switzerland).

Unlike medicinal products, medical devices do not usually require a marketing authorisation but, on the other hand, must generally bear the CE mark in order to be freely circulated in the EU.

The regulatory framework for medical devices, while undoubtedly valuable, has come under fire on a number of occasions, recently following the worldwide scandal surrounding PIP breast implants. Indeed, it was revealed that these French implants are more prone to rupture and leakage than others due to the fact that they contain unapproved industrial silicone rather than medical-grade fillers.

To avoid such problems in the future, the competent authorities and medical devices sector are currently working together to revise and reinforce the regulatory framework applicable to medical devices.

In this regard, the European Commission recently adopted and submitted to the European Parliament and the Council two proposals for regulations on medical devices. A key measure in the reform is the introduction of a Unique Device Identification (UDI) system, which will enhance the post-market safety of medical devices, help to reduce medical errors, and contribute to the fight against counterfeiting.

In Belgium, the Minister of Social Affairs and Public Health, Laurette Onkelinx, did not wish to await completion of the European reform and has already prepared a plan to enhance monitoring of the sector and ensure better traceability of medical devices. In implementing the plan, priority will be given to implantable medical devices, which are considered to pose greater risks.

This ambitious reform should be completed by 2016. Indeed, working groups are currently thrashing out measures to implement the main pillars of the plan, namely improved identification and traceability of medical devices and enhanced monitoring and materiovigilance (i.e. the monitoring of possible incidents associated with the use of medical devices). These measures will have to be passed by royal decree, in line with the future European measures.

Improved identification and traceability

The plan provides for the mandatory...

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