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European Union agrees new rules on medical devices

MDBR Staff Writer Published 27 May 2016

The European Union (EU) has agreed new rules on medical devices and in vitro diagnostic medical devices.

A political agreement has been reached by the Netherlands presidency of the Council and representatives of the European Parliament.

The deal is still subject to the approval by the Council's Permanent Representatives Committee and of the Parliament's ENVI committee.

The agreed two draft regulations intend to ensure that medical devices and in vitro diagnostic medical devices are safe and enable patients to benefit from new health care solutions in a timely manner.

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

The deal intends to strengthen the rules on placing devices on the market and tighten surveillance after the products availability.

Netherlands Minister of Health and president of the Council Edith Schippers said: "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."