The implementation of Regulation (EU) 2017/745 (MDR) is critical for ensuring patient safety, transparency, and access to Medical Devices for European citizens.
COCIR, which represents the united industry voice of the Medical Device manufacturers in medical imaging, radiation therapy and digital health sectors, welcomes the elements of a legislative proposal presented by the European Commission during the EPSCO Health Council, on 9 December 2022.
The proposed actions are an important step to avoid bottlenecks in MDR certification towards 2024, ensure access to the market to all devices and, ultimately, guarantee continuity of patient care across Europe. COCIR Members believe that extending certificates provided under the Medical Devices Directives would allow Notified Bodies to free up capacity and distribute their workload to focus on MDR certificates for new products. At the same time, it would secure patients’ access to safe legacy devices beyond the transitional period deadline, in May 2024.
COCIR appreciates the significant effort by the European Commission and Member States to avoid shortages of Medical Devices in Europe. We encourage the European Parliament and the Council to ensure a swift adoption of the proposal. Our Members stand ready to cooperate in the implementation of the Medical Devices Regulation in order to guarantee access to safe devices and the continuum of health care provision for EU patients.