Abstract
The Medical Devices Directives were developed in the 1990s under the framework of Europe's “New Approach” to regulation and in response to the threat of proliferation of regulatory systems around Europe. The legislation therefore addressed the need for the free movement of goods in the single market as well as the protection of public health by ensuring that only safe product was placed on the market. It is widely recognized 1 that this EU system has served society well and has been instrumental in delivering safe products to patients for nearly twenty years.
There are three directives. The first to be introduced covered active implants; for example pace makers. The second directive addressed the vast majority of devices ranging from syringes to scanners. In vitro diagnostics also fall under the classification of medical devices and this led to a third directive being added to the ‘medical device directive family’ to specifically regulate this product sector. In vitro diagnostics are widely used to prevent ill-health and to allow some patients to manage their own disease in addition to their use in diagnosing disease and monitoring drug therapy.
Medical technology plays a crucial role in keeping the European population healthy and productive by delivering innovation into healthcare, while also contributing to the European knowledge-based economy. The MedTech sector's ability to continue the delivery of safe and efficient life-enhancing products and services for patients and consumers is based on its strong innovative capacity. In turn, innovative capacity is dependent on the existence of an appropriate and smart EU-wide regulatory framework. This framework must provide for patient access to safe, high-quality healthcare products while allowing for the timely introduction of innovation.
Today it is also recognized that there is a need to modernize and strengthen the current legislation. In mid-2012 the EU Commission will present a proposal for the revision of the devices directives which is likely to lead to the first two directives being combined in a single regulation. The In Vitro Diagnostics directive will also be revised and will remain separate as a distinct regulation for the in vitro diagnostics sector. This forthcoming EU Commission proposal for revision of the system is therefore likely to focus on better designation and control of notified bodies, improved post-market surveillance throughout the supply chain, greater transparency and improved coordination by member state authorities while at the same time leaving the fundamental principles of the system unchanged.
In summary, the renewed framework should provide for a consistent, EU-wide regulatory approach, through improved coordination, evaluation and certification of medical devices; consistent and comprehensive implementation across all EU member states as well as efficient vigilance and post-market surveillance systems. If this is done properly, it will help preserve the innovative capacity that is crucial to achieving quality care for patients as well as innovation and economic growth.
Association of British Healthcare Industries (
British In Vitro Diagnostics Association (
Advanced Medical Technology Association (