MDR, 2021 may 26th, Date of Application is now !
By Virginie GAIFFE / On May 25th, 2021 / In Events, Health, Other, Regulatory
The 26th May 2021 marks the full application of the new EU Regulation on Medical Devices (MDR. Regulation (EU) 2017/745).
The MDR represents a significant update to the existing medical device Directives which have been in place for 30 years. The MDR aims to strengthen and improve the regulatory system for medical devices in Europe to ensure that medical devices are safe and perform as intended over their lifetime. It also aims to ensure that innovation and development of new technologies is supported in Europe to afford patients and health systems new diagnostic and therapeutic options.
The CAMD has been working closely with the EU Commission and all relevant stakeholders over the last number of years on implementation of the new MDR.
The CAMD are committed to continue work on the effective and consistent application of the MDR and to ensure its core objectives to provide for a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.
In addition to this the CAMD continues to work with the EU Commission on implementation of the EU Regulation on In-Vitro Diagnostics (IVDR. Regulation 2017/746) which is due to become fully applicable in May 2022.
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