New EU Regulation on MDD
New European legislation on Medical Devices !
The sector of medical devices is, especially in Europe, an extremely innovating sector with an estimated market value of approximately 95 billion euro. To assure that the medical devices sold in Europe continue to provide in the needs of the population, and be safe at the same time, the European Commission has recently presented two new regulations to this effect and that will be more transparent and better suited to scientific and technological developments. These new regulations have to guarantee that patients, consumers and health care professionals can benefit from safe, efficient and innovating medical devices.
At this very moment, medical devices are being regulated by three directives. Most medical devices in the EU have to comply with the Medical Device Directive MDD 93/42/EEC, amended by Directive 2007/47/EC in effect since March 2010. Other groups of medical devices are regulated by specific directives, such as the in vitro diagnostic devices that have to comply with Directive 98/79/EB and the active implantable medical devices that have to comply with Directive 90/385/EEC, also amended by Directive 2007/47/EC.
The existing legal framework has given proof of its value. However after 20 years it has to be revised, which is indeed the case for all regulations on innovating products. Moreover, the legislation has been under attack in the press and by politicians when the French public health authorities discovered that a French producer (Poly Implant Prothèse, PIP) had used industrial instead of medical silicones for the production of breast implants, contrary to the approbation issued by the notified body, with thousands of female victims across the world.
Copyright Photo Le Monde : Approximately 30 000 women in France, and 400 000 to 500 000 other women across the world are carrying potentially defective breast implants made by Poly Implant Prothèse (PIP), La Seyne-sur-Mer (Var).
In September 2012 the European Commission submitted a proposal for a new Regulation on the control of medical devices to the Council of the European Union and the co-approval of the European Parliament. It is important to note that a Regulation in contrast to a directive immediately comes into effect for all European member states, without prior transposition into national legislation. As a consequence, a regulation is the most binding legislative instrument in the European Union.
The most important element in the proposition are:
- a broader and clearer field of application of the EU legislation, that will be expanded to e.g. implants for aesthetic purposes and including clarification concerning e.g. medical software. This will result in a correct evaluation of the safety and performances of these products before they are introduced in the EU market
- sharper control of independent certification instances by the national authorities
- more authority and obligations for the certification instances to guarantee thorough testing and periodic controls of manufacturers, including unannounced inspections on site and sampling
- clearer rights and responsibilities for manufactures, importers and distributors, that also apply to diagnostic services and online sales
- comprehensive European database for medical devices with elaborate and public information on products that are sold in the EU market. Patients, health workers and the public at large will have access to important data on medical devices in Europe, allowing them to take better founded decisions
- better traceability of devices in the supply chain in order to intervene more quickly and efficiently in the case of a health related issue. A unique medical device identification system will be introduced to enhance the safety of medical devices after their introduction into the EU market, to diminish the number of medical mistakes and to prevent counterfeit
- stricter requirements for clinic evidence to guarantee the safety of patients and consumers
- adaptation of the prescriptions to the scientific and technological progress, e.g. adaptation of safety and performance requirements for new health related technologies, such as software applied in health care of nano-materials
- better coordination between national inspection authorities to assure that only safe devices are introduced into the EU market
- adaptation to international directives to facilitate international trade
It is foreseen that the proposal will be approved in the course of 2014 and that the new regulations will then be gradually introduced in the period between 2015 and 2019.