Ambitious Reform of the Medical Devices Regulatory Framework

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 registration of any implantable medical device upon entry into distribution in Belgium. The manufacturer or distributor must submit information about the quality, security and efficacy of the device to the Federal Agency for Medicines and Health Products as well as to the pricing and reimbursement authorities.

This registration requirement will be phased in progressively, in April 2014 for the most common implants (e.g. hip prostheses and pacemakers) and April 2016 for all other implantable devices.

In addition, every implant placement must be registered by the relevant healthcare professional by April 2014. Healthcare professionals must also provide the patient with a so-called implant card containing useful information about the device (eg. date of expiry). This card serves as the patient's guarantee that the implant has been distributed through lawful channels.

This system will allow the authorities, in the event of problems, to know at any given time where a device is located and to alert the healthcare professionals and patients concerned.

Enhanced monitoring and safety

In October 2013, a new framework for the supply of medical devices will be introduced, involving (public and hospital) pharmacies.

In order to allow better monitoring of the sector by the authorities, the plan provides, amongst other things, for the reinforcement of inspections at manufacturers, distributors, hospitals and private clinics. The authorities will recruit 41 additional inspectors for this purpose. These heightened measures are already being felt in the sector of implantable devices, which has witnessed a sharp increase in the number of inspections since September.


Finally, the plan provides for the introduction of materiovigilance contact points and a mandatory standard procedure to notify incidents to the authorities. These obligations will be applicable to any party that supplies or makes available a medical device. Hospitals and distributors will be allowed to comply with these measures on a voluntary basis as from January 2013. They will however become mandatory for everyone in the sector in October 2013.

"The Belgian reform of the medical devices sector, which originates from the PIP scandal, has given rise to real 'screening' of the entire regulatory framework applicable to medical devices and will guarantee patients safer and better monitored devices", explains Richard Van den Broeck, director of UNAMEC, the Belgian trade association for the medical devices sector. "It is a very ambitious reform, whose implementation will be complex given the diversity in the sector. UNAMEC is in favour of reasonable implementation of the plan, so that the various players in the sector can continue to function 'normally', without unreasonable administrative burdens, while continuing to foster innovation and preserving competitiveness."

Finally, as the sector has agreed to finance the plan, it should be cost-neutral for the Belgian federal budget.