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.
It is expected that the upcoming 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.
To understand the implications of the new legal obligations for researchers, businesses and other innovators, the AAL Programme will soon release a paper highlighting the effects onf the regulation on medical devices aiming at improving the quality fo life of older adults. The paper is expected to be published by mid-March 2021.
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