Implementing the Medical Device Regulation – will we be ready for May 2020?

26 November 2018 marked the exact mid-point in the implementation period of the Medical Device Regulation (MDR). On that occasion, COCIR decided it is the right time to assess if the development of secondary legislation, including implementing & delegated acts, guidance, and harmonisation of standards, is moving forward. Based on our earlier contribution to the implementation, we outlined the progress on the top priority areas for our membership and formulated nine recommendations to map the way forward.

The Medical Device Regulation was a much-needed step to further harmonise the European market. Delays in its implementation would impact European healthcare systems and citizens as well as manufacturers that strive to be compliant. Innovative medical devices make the delivery of healthcare safer, more efficient and more effective. Regulators need to ensure that they continue to reach patients on time. To reach that common goal, COCIR is looking forward to continuing collaboration and contributing our members’ expertise in the months to come.

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