Brussels, 17 October 2013 – The Internal Market and Consumer Production (IMCO) Committee of the European Parliament voted today on the proposed amendments to the draft Consumer Product Safety Regulation.
COCIR, the European Radiological, Electromedical and Healthcare IT Industry association, promotes research and innovation in the medical devices field as key enablers of both safe healthcare and economic growth. COCIR members’ products and services have steadily increased the quality of healthcare delivery, while ensuring the highest safety for patients.
Innovation in the medical devices industry and the health benefits that result from this innovation both rely on smart regulation at the EU level. To this end, COCIR applauds the decision of the IMCO Committee to exclude medical devices from the scope of the draft Consumer Product Safety Regulation.
COCIR Secretary General, Nicole Denjoy said, “The provisions of the draft Consumer Product Safety Regulation are already covered in the existing EU Medical Devices Directive, in many cases and in more detail. Including medical devices in the Consumer Product Safety Regulation would have been an unnecessary and legally confusing instance of duplication and overlap.”
COCIR supports strengthening traceability through the ongoing legislative process to replace the Medical Devices Directive with a new Medical Devices Regulation. COCIR calls on all Members of the European Parliament to reaffirm the IMCO Committee’s position during the upcoming plenary vote scheduled for 11 March 2014.
For more information, contact:
COCIR Secretary General
Tel: +32 (0)2 706 8961
COCIR Communications Advisor
Tel: +32 (0)496 116198
Notes to Editors
In February 2013, the European Commission adopted a new Product Safety and Market Surveillance Package, including a proposal for a new Regulation on consumer product safety (to replace Directive 2001/95/EC on general product safety).
The European Parliament published its Draft Report in June 2013. In September 2013, the IMCO Committee of the European Parliament introduced a number of amendments to the draft Consumer Product Safety Regulation, including two amendments to exclude medical devices from the scope of the proposed Regulation.
The IMCO Committee voted in favour of the amendments on 17 October 2013.
The vote in EP Plenary Session is currently scheduled for 11 March 2014.