COCIR Urges Caution on the Call for an Alternative Marketing Authorisation Procedure for Medical Devices

European Commission’s proposal is a better balance for patient safety and timely access to innovative technologies in Europe

COCIR* notes the recent publication of Rapporteurs’ reports by The European Parliament’s ENVI, IMCO and EMPL Committees on the European Commission’s proposal for a Medical Devices Regulation.  COCIR congratulates the Rapporteurs on the speed and thoroughness of their reports and is grateful for the opportunity to engage in dialogue with stakeholders, as arranged by MEP Dagmar Roth-Behrendt, Rapporteur for the ENVI Committee.

COCIR agrees with the Rapporteurs that the current regulatory framework for medical devices needs to be modernised and strengthened.  The Commission’s proposal would improve the product evaluation process, enhance the traceability of products, place more scrutiny on Notified Bodies, harmonise EU Member States’ authorities’ approach to regulation and improve the exchange and coordination of information, especially in the post-market phase.

The most significant change put forward is the proposal by Rapporteur Roth-Behrendt for the creation of alternative marketing authorisation process for Class III and other “innovative” devices.  COCIR is sceptical of the possible claimed benefits of such a new system.
Nicole Denjoy, COCIR Secretary General, said, “We envisage that this proposal will result in additional complexity, delays and costs to the European medical devices sector.  It is unclear whether a new Committee within Europe’s pressurised Medicine Agency, which has no experience in devices, would provide additional benefits to patients or healthcare providers seeking speedy access to new products and innovative technologies - or meet the ever rising demands for healthcare and improved efficiency.”

“We believe the Commission’s draft Regulation, developed over several years of extensive consultation, strikes a proper balance between patient safety and access to life-saving medical equipment.  COCIR will be commenting on each of the Rapporteurs’ reports in depth and will be urging MEPs to focus on proposals which will improve and clarify the Commission’s draft, rather than seek to introduce radical changes to the regulatory regime in Europe which will diminish timely access to life-saving technologies by European citizens,” added Nicole Denjoy.

*COCIR represents the European Medical Imaging, Electromedical and Healthcare ICT Industry.


For more information contact:

Nicole Denjoy
COCIR Secretary General    
Tel: +32 (0)2 706 8961
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For press questions please contact:

Kathryn Sheridan
COCIR Communications Advisor
00 32 (0) 496 116198
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