COCIR welcomes the endorsements on 15 June of the agreement on the Medical Devices Regulation (MDR) by the Council's Permanent Committee (COREPER) and by the European Parliament’s Environment, Public Health and Food Safety (ENVI) Committee.
COCIR and its members view this endorsement as an important step in bringing this process closer to its conclusion and potential adoption later this year. However, COCIR still believes that once adopted, important work remains during the implementation phase to ensure realistic rules for regulators, industry and other stakeholders that minimise unnecessary bureaucracy and red tape.
Nicole Denjoy, COCIR Secretary General said; “COCIR and its member companies are actively and carefully analysing the consolidated negotiated text. This will allow for appropriate planning for timely compliance to the MDR at the point when applied across the European Union (expected in 2019-2020). However, we remain concerned by the transition period of three years.” She added; “It is also evident that secondary legislation is of importance to COCIR and its member companies. We will evaluate in greater depth once those will start to become available”.
“We continue to call for smart regulations, supported by state-of-art standards. Together, these will ensure the highest level of safety and quality for patients and citizens while simultaneously fostering innovation” she concluded.
The consolidated negotiated text will now undergo legal review and translation into the EU’s 24 official languages. This should be finalised before the end of the year/beginning of next year.
For more information, contact:
Nicole Denjoy
COCIR Secretary General
Tel: +32 (0)2 706 8961
denjoy@cocir.org
Colin Mackay
COCIR Communications Senior Advisor
Tel: +32 (0) 473 43 07 52
press@cocir.org