Brussels, 26/09/2012 (Agence Europe) - On 26 September, the European Commission unveiled a draft update of existing rules for medical devices in two new regulations, one on medical devices and one on invitro diagnosic devices. The proposals were eagerly awaited in the wake of the scandal of dangerous PIP breast implants, that revealed shortcomings in the current rules and gave rise to massive fraud. 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… 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.”
The medical device industry is very innovative in Europe and makes an annual turnover of some €95 billion, covering a wide range of some ten thousand different products from simple adhesive dressings to the most sophisticated life-support machines. The breast implant scandal at the end of last year highlighted gaps in the rules and lack of coordination among the authorities concerned at both national and EU level, lack of traceability of raw materials and unsafe, ineffective devices, along with insufficient spot checks on manufacturers. The new legislation unveiled by the Commission will be of benefit to consumers, patients, healthcare professionals and manufacturers alike. 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 and control processes will be 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; and 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 main elements of the proposals are:
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 proposals are now being examined by the EU Council of Ministers and the European Parliament. (IL/transl.fl)