Local view for "http://purl.org/linkedpolitics/eu/plenary/2017-04-04-Speech-2-439-500"
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"en.20170404.22.2-439-500"1
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"The medical devices sector, representing more than 25,000 companies of which 95% are SMEs, has not only become an influencer on expenditure, but also increasingly important for the healthcare of EU citizens, covering a wide range of products, from simple bandages to heart valves, and the most sophisticated X-ray equipment. It helps improving the quality of life of citizens by providing innovative health care solutions regarding diagnosis, prevention, monitoring, treatment and alleviation. Since the existing regulatory framework dated back to the 1990s, only considering the advances of technology in the medical sector there was a stringent need for revision. The new Regulations on medical and in-vitro diagnostic medical devices will help to ensure that all medical devices are safe and perform well, and will make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and technological state-of-the art, but also comply with EU patient safety and ethical requirements. The rules will also improve market surveillance and traceability, and provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector. I strongly support the outcome reached."@ro2
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