EU Updates Standards for Medical Devices 2024/815

The European Commission recently issued a decision updating standards for medical devices, aiming to ensure their safety and efficacy. The decision, published in the Official Journal of the European Union on March 8, 2024, revises several harmonized standards related to medical gloves, biological evaluation, sterilization, packaging, and processing of healthcare products.

Decision for 2024/815

The decision stems from Regulation (EU) No 1025/2012 and Regulation (EU) 2017/745, which emphasize European standardization and the conformity of medical devices with relevant standards. The Commission, in collaboration with European standardization bodies, revised existing harmonized standards and developed new ones to align with the latest technological advancements and regulatory requirements.

Key updates include revisions to standards such as EN 455-3:2023 for medical gloves, EN ISO 10993-15:2023 for biological evaluation, and EN ISO 11607-1:2020/A1:2023 for packaging of terminally sterilized medical devices. These standards aim to ensure the quality, safety, and performance of medical devices in compliance with EU regulations.

The decision emphasizes that compliance with these harmonized standards provides a presumption of conformity with essential requirements outlined in EU legislation. The updated standards are essential for manufacturers, healthcare professionals, and regulatory authorities to guarantee the reliability and safety of medical devices in the European market.

The decision, effective upon publication, signifies the ongoing commitment of the European Union to uphold high standards of quality and safety in healthcare products. It underscores the importance of continuous improvement and adaptation to emerging technologies and regulatory changes in the medical device industry.

2024/815 link

For more information, refer to the official publication in the Official Journal of the European Union (Issue L, 2024/815) or visit the European Commission's website.