Medical Devices: Agreement reached on new EU rules

On 25 May 2016, new rules were agreed on medical devices and in vitro diagnostic medical devices. 

Under the Dutch presidency, the European Council and representatives of the European Parliament reached a political agreement. This agreement is subject to the approval by the Council's Permanent Representatives Committee and of the Parliament's ENVI Committee.

The agreed two draft regulations are expected to achieve a twofold aim: making sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in a timely manner.

Medical devices and in vitro diagnostic medical devices cover a wide range of products, from sticking plasters to hip replacements, and from pregnancy tests to HIV tests. 

"This agreement matters to all citizens: sooner or later all of us enter into contact with medical devices to diagnose, prevent, treat or alleviate diseases. The deal reached will improve patients' health and it will help to enhance the quality of life of disabled persons. It will also ensure a level playing field for the 25,000 medical devices manufacturers in the EU, many of which are SMEs and which employ more than half a million persons", said Edith Schippers, Minister of Health of the Netherlands and President of the Council.

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