AAL Programme on the new EC Medical Devices regulation
The AAL Programme has issued a special report on the latest EU Medical Device Regulation to help the the AAL community in understanding the legislation and its requirements. It also provides perspective on how the Medical Device Regulation affects the development of solutions targeting active and healthy ageing.
The European Commission has come out with a plan to adopt a number of new regulations to modernise the current system of classification and control of medical devices, which will include such aspects as new classification system, improved transparency through EU database, reinforcement of the rules on clinical evidence and more.
The Medical Devices Regulation (MDR) issued by the European Commission ‘will create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers and healthcare professionals’.
The new regulation will affect the development of technological innovations across all health care areas, also directly including the latest products and services for older adults and chronic diseases.
If you are interested to learn more ,the European Commission has issued a set of factsheets targeting different health innovation professionals Dedicated factsheets.