lunedì 13 luglio 2015

MEDICAL DEVICES: COUNCIL GETTING READY FOR TALKS WITH EP


On 19 June 2015, the Council agreed the substance of its negotiating stance on two draft regulations aimed at modernising EU rules on medical devices and in vitro diagnostic medical devices. This is a step towards providing the presidency with a mandate to start talks with the European Parliament with a view to reach an agreement as early as possible.
The two draft regulations on medical devices cover a wide range of products, from sticking plasters to hip replacements, pacemakers and laboratory tests for assessment of medical interventions.  
The main objective of the two draft regulations is to ensure that medical devices are safe. This would be achieved by strengthening the rules on placing devices on the market and tightening surveillance once they are available.

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