On 6th March, the EU Commission issued two significant decisions, EU 2024/817 and EU 2024/815, focusing on updating the list of harmonized standards relevant to medical devices and in vitro diagnostic devices (IVDs). These decisions introduced amendments to Implementing Decisions EU 2021/1182 and EU 2021/1195, respectively, which covered various aspects such as medical gloves for single use, biological evaluation of medical devices, sterilization of healthcare products, packaging for terminally sterilized medical devices, and processing of healthcare products.
Following the implementing decisions of 6th March, the EU has published the updated Harmonized Standards List for MDR and IVDR. These standards are comprehensive and easier to follow compared to the implementing decisions.
You can find the MDR list here, and the IVDR list here.
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If you’re not sure how these updates impact your medical device or IVD, or need support in meeting the required standards, please contact us so we can help you.