News New medtech regulations Newsletter

Progress in recognition of harmonised standards under MDR and IVDR

Posted on 04.04.2024

The European Commission has added new references for harmonised standards. These Commission Implementing Decisions, published on 8 March 2024, in the Official Journal of the European Union, signify the latest advancements in medical device standards.

Commission Implementing Decision (EU) 2024/815, under the MDR, broadens references across various medical device categories, such as medical gloves for single use, biological evaluation, sterilisation of health care products, packaging for terminally sterilised medical devices, and processing of health care products. This decision marks the ongoing evolution of medical device standards, now totalling 25 references.

Commission Implementing Decision (EU) 2024/817, under the IVDR, adds references for the sterilisation of healthcare products and packaging for terminally sterilised medical devices. With these additions, the total references for IVDR standards reach 13.

We appreciate the European Commission’s dedication to innovation and maintaining safety and quality in medical and in vitro diagnostic devices. MedTech Europe advocates for continued collaboration to expand the list of harmonised standards, which are essential tools for regulatory compliance.

For more information, please contact Carlos Pérez, Manager Medical Devices.