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EU Council, Parliament reach agreement on rules for medical devices

May 26, 2016

The European Union agreed to new rules on medical devices and in vitro diagnostic medical devices following a trilogue meeting on May 25, 2016, according to a European Council press release. 

The Netherlands presidency of the council and representatives of the European Parliament reached a political agreement, which is subject to approval by the European Council’s Permanent Representatives Committee and the European Parliament’s Environment, Public Health and Food Safety Committee. The two agreed-on draft regulations are expected to achieve a two-fold aim: to ensure medical devices and in vitro diagnostic medical devices are safe; and to allow patients to benefit from innovative health care solutions in a timely manner. Medical devices and in vitro diagnostic medical devices cover a wide range of products, which includes sticking plasters and hip replacements.

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