HEALTH : MEDICAL DEVICES STILL ON LEGISLATORS' TABLE.

Policy makers in charge of public health will be focusing almost exclusively on the legislative proposals on medical devices and in vitro medical devices - the Greek EU Presidency's top priority. Athens was spared having to steer through the Tobacco Products Directive and the clinical trials regulation thanks to the last-minute agreement worked out in three-way talks. Nor will it have to tackle recent proposals on novel foods and foods obtained from cloned animals, which will now be dealt with by the Council's agriculture configuration.

There is consequently a real likelihood of seeing the Council move forward on the legislative proposals on medical devices, placed on the back burner until now due to their highly technical and unwieldy nature (some 200 articles and 30 annexes).

The European Commission proposed, in September 2012, to tighten up rules on the safety and effectiveness of medical devices in the wake of the scandal over faulty breast implants manufactured by the French firm PIP. The proposals would set up a monitoring procedure for risky products, strengthen the powers and responsibilities of notified bodies (in charge of assessing product conformity) and enhance product traceability through a unique device identification mechanism. Parliament has been ready to negotiate since October 2013, but the Council has yet to adopt a common approach, despite 20 or so working group meetings. At...