The recent adoption by the European Parliament of two Regulations on medical devices and in vitro diagnostic medical devices signifies peace of mind for all EU citizens.
Ranging from simple contact lenses and plasters to sophisticated pacemakers and hip replacements, medical devices and in vitro diagnostic medical devices are indispensable for our health and quality of life.
The new rules will replace current rules on the safety and performance of medical devices adopted in the 1990s and which were considered by the European Commission to be outdated. Furthermore, certain scandals in Europe involving breast implants strengthened the European Commission’s resolve to pave the way for a stronger legal regime which would regulate the use and safety of medical devices.
All medical devices, in vitro diagnostic medical devices and their accessories, ranging from heart valves to sticking plasters and artificial hips, fall within the scope of the new Regulations. Certain aesthetic products such as coloured contact lenses or equipment for liposuction – that need to be just as safe as medical devices – are also covered.
The new Regulations encourage a more patient-friendly environment where transparency and patients’ information and choice rank high. Tighter pre-market controls on high-risk devices such as implants is ensured. Controls on clinical trials as well as on the bodies that can approve the marketing of medical devices have also been tightened. For certain high risk devices, the new regulations require the notified bodies to consult with an expert panel before placing the device on the market. A new system for risk classification in line with international guidelines will apply to in vitro diagnostic medical devices.
Stricter requirements on the use of hazardous substances have been introduced. The new Regulation on medical devices lays down a classification system for devices incorporating or consisting of nanomaterials. The critical factor is the potential for nanomaterials to be in contact with membranes inside the body. Those devices presenting a high or medium potential for such contact will fall under the highest risk class and thus be subject to the most stringent conformity assessment procedures.
The new Regulations will ensure that vital information is easily available. A comprehensive EU database on medical devices (EUDAMED) will contain a living picture of the lifecycle of all products available on the EU market. A unique device identifier will be mandatory for every product so that it can be traced in this database. In terms of the new rules, patients having implants will receive an implant card with all the essential information.
Once devices are available for use on the market, manufacturers will now be obliged to collect data about their performance.
A robust financial mechanism to ensure patients are compensated in case that they receive defective products will also be put in place, with manufacturers required to have sufficient financial coverage for any potential liability. Such coverage will be proportionate to the risk class, type of device and the size of the enterprise. This should allow patients to be rapidly and effectively compensated for any damages sustained, even in those cases where the relevant company goes bankrupt.
An efficient European-wide mechanism will be put in place for the regulatory management of medical devices. It will allow more frequent exchange of information so that regulatory decisions by either member states or the European Commission can be taken on a more informed basis.
In this way, it should be easier to address safety issues and scandals within Europe.
The medical devices industry is a major employer in Europe, employing some 575,000 persons in the EU and with total sales amounting to €100 billion. Ensuring a level playing field for all players is therefore an important pre-requisite for those who would like to penetrate this market. Furthermore, the health of those citizens who make use of any medical device comes first and foremost – hence the necessity for stringent rules which regulate this sector.
Mariosa Vella Cardona is a freelance legal consultant specialising in European law, competition law, consumer law and intellectual property law.
mariosa@vellacardona.com