BRUSSELS – 6 October 2015 – COCIR welcomes yesterday’s successful Council endorsement of its negotiating position confirming the General Approach and the imminent start of the Trilogue process for the proposed Medical Devices Regulation (MDR). COCIR wants to use this opportunity to ask the EU Institutions to capitalise on the current regulatory framework and hopes that the final agreed regulation will be robust, transparent and open to innovation.
COCIR has been monitoring the evolution of this draft regulation since the beginning and urges all parties involved in the revision process to consult its High Level Contribution on the Proposal for MDR summarizing Industry opinions and outlining 13 key recommendations, based on the latest proposals.
With regards to pre-market phase, COCIR support actions already taken to strengthen Notified Bodies performance. We support the position of the Council to limit the scrutiny procedure to implantable medical devices in Class III to avoid unnecessary and unpredictable delays for other medical devices which would undermine patient safety, innovation and competitiveness.
With regards to clinical data and investigations, the current positions of the three EU Institutions still do not recognise the major differences between medical devices and pharmaceutical products. COCIR urges calls for clinical requirements to be tailored to the unique characteristics of medical devices. COCIR also hopes EU Institutions will be able to clarify requirements linked to ‘Software as a Medical Device’, and ensure an international convergence based on work by the International Medical Device Regulators Forum (IMDRF).
While pre-market requirements remain important, there is a need to have a robust post-market phase. Such a system must have unambiguous and fair obligations for all parties involved in the placing and use of medical devices. In this context, we warn EU Institutions on keeping pragmatic approaches on ways of reporting serious incidents to Competent Authorities.
Nicole Denjoy, COCIR Secretary General, says, “Such a key regulation will have to be properly deployed and implemented at country level. A three-year transition period is not long enough for such an important piece of regulation. We want a five year transition period for medical device manufacturers.”
She adds, “As pressure continues to mount, supporting medical innovation is crucial for delivering sustainable healthcare systems. Medical devices and health ICT play a crucial role delivering care to Europe’s patients. As the policy process enters a more detailed crucial phase, stakeholder dialogue has never been more important. We need to ensure the proposed MDR not only strengthens existing legislation, but also stimulates technological innovation, improves market access, and provides optimised patient safety.”
For more information, contact:
COCIR Secretary General
Tel: +32 (0)2 706 8961
COCIR Communications Advisor
Tel: +32 (0)496 116198