The new rules aim to ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices. The medical device sector is highly innovative, particularly in Europe and has an estimated market value of around €95bn.
Health and Consumer Policy Commissioner John Dalli said "Just a few months ago, everybody was shocked by the scandal involving fraudulent breast implants which affected tens of thousands of women in Europe and around the world. As policy makers, we must do our best never to let this happen again. This damaged the confidence of patients, consumers and healthcare professionals in the safety of the devices on which they rely every day. The proposals adopted today significantly tighten the controls so as to ensure that only safe devices are placed on the European Union's market at the same time, they foster innovation and contribute to maintaining the competitiveness of the medical device sector."
Who will benefit?
Patients and consumers since all devices will have to undergo thorough assessment of safety and performance before they can be sold on the European market. Control processes are radically reinforced, but continue to ensure rapid access to innovative, cost-effective devices for European patients and consumers.
Healthcare professionals will be provided with better information on the benefits for patients, residual risks and the overall risk/benefit ratio, helping them make the best use of medical equipment in their treatment and care of patients.
Manufacturers will benefit from clearer rules, easier trading between EU countries and a level playing field that excludes those who do not comply with the legislation. The new rules support patient-oriented innovation and take particular account of the specific needs of the many small and medium-sized manufacturers in this sector.
Main elements of the proposals include:
- Wider and clearer scope of EU legislation, extended to include, for example, implants for aesthetic purposes, and clarified for instance, as regards medical software. This will ensure that the safety and performance of these products are correctly assessed before they are placed on the European market;
- Stronger supervision of independent assessment bodies by national authorities;
- More powers and obligations for assessment bodies, to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections and sample testing;
- Clearer rights and responsibilities for manufacturers, importers and distributors, applying also to diagnostic services and internet sales;
- Extended database on medical devices, providing comprehensive and public information on products available on the EU market. Patients, healthcare professionals and the public at large will have access to the key data concerning medical devices available in Europe, allowing them to make better informed decisions;
- Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns. A Unique Device Identification system will be introduced to enhance post-market safety of medical devices, to help to reduce medical errors and to fight against counterfeiting;
- Stricter requirements for clinical evidence, to ensure patient and consumer safety;
- Adaptation of the rules to technological and scientific progress, for example the adaptation of the safety and performance requirements applicable to new health technologies, such as software or nanomaterials used in healthcare;
- Better coordination between national surveillance authorities, to ensure that only safe devices are available on the European market;
- Alignment to international guidelines, to facilitate international trade.
The revised regulatory framework for medical devices is comprised of the following:
- A proposal for a Regulation on medical devices (to replace: Directive 90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC regarding medical devices);
- A proposal for a Regulation on in vitro diagnostic medical devices (to replace Directive 98/79/EC regarding in vitro diagnostic medical devices).
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