EC Seeks Revisions from Standardization Groups

May 3, 2021

The European Commission has asked European standardization groups to revise more than 200 existing harmonized standards and to draft 27 new standards over the next three years to support the EU’s Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR).

The commission called on the European Committee for Standardization and the European Committee for Electrotechnical Standardization to revise the harmonized standards that underpin Europe’s new device regulations.

The standards should include detailed technical specifications relating to the requirements set out in the MDR and IVDR, the commission said, “especially with respect to the design and manufacture of devices, risk management and the obligations on economic operators and sponsors, including those relating to quality management systems, risk management, clinical investigations and performance studies, and clinical evaluation and clinical evidence.”

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