The European Commission acknowledged nine harmonised standards for medical devices on Tuesday, which device producers can use to meet the Medical Devices Regulation’s conformity requirements (MDR).
The standards address a variety of areas, including medical device biological evaluation, sterilisation, aseptic processing, quality management systems, and the use of symbols in product information, among others.
The nine new harmonised standards join a previous batch of five harmonised standards certified by the commission in July 2021, bringing the total number of harmonised standards to 14. The standards were recognised after the European Commission requested revisions from the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec).
Devices that comply with applicable harmonised standards, or relevant parts of those standards, whose references have been published in the Official Journal of the European Union, are presumed to comply with the Regulation’s requirements covered by those standards or parts thereof.