The European Commission on Tuesday officially recognized nine harmonized standards for medical devices that device makers can reference in order to satisfy conformity requirements under the Medical Devices Regulation (MDR).
The standards cover topics including the biological evaluation of medical devices, sterilization, aseptic processing, quality management systems, the use of symbols in product information, and more.
The nine newly recognized harmonized standards follow an earlier set of five standards that the commission recognized in July 2021, bringing the total number of harmonized standards to 14. The recognition of the standards follows the Commission’s request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) to revise.
According to the Commission, “devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.”
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