The ISO/DIS 20417 standard, titled "Medical Devices — Information to Be Supplied by the Manufacturer," provides key guidelines to ensure that manufacturers deliver clear, consistent, and comprehensive information with their medical devices. Published on November 29, 2024, the draft focuses on essential elements such as instructions for use, safety warnings, and performance details, aiming to standardize the information manufacturers must provide. This initiative is crucial in improving transparency and usability, benefiting both healthcare professionals and end users, while enhancing patient safety. The updated standard also addresses the increasing complexity of digital and software-based devices, ensuring manufacturers meet regulatory compliance and facilitate global market access. Stakeholders in the medical device industry are encouraged to review and provide feedback to help shape the final version of this important standard.

The latest 𝗤&𝗔 𝗼𝗻 𝗔𝗿𝘁𝗶𝗰𝗹𝗲 𝟭𝟬𝗮 is here, and it is essential reading for all medical device and IVD professionals! This comprehensive guide covers the new 𝗼𝗯𝗹𝗶𝗴𝗮𝘁𝗶𝗼𝗻 𝘁𝗼 𝗶𝗻𝗳𝗼𝗿𝗺 in cases of 𝘀𝘂 𝗽𝗽𝗹𝘆 𝗶𝗻𝘁𝗲𝗿𝗿𝘂𝗽𝘁𝗶𝗼𝗻 𝗼𝗿 𝗶𝘀𝗰𝗼𝗻𝘁 𝗶𝗻𝘂𝗮𝘁𝗶𝗼𝗻, ensuring that patients' access to life-saving devices is never compromised.

Team-NB has published a press release on the implementation of the MDR/IVDR regulations. They advocate several measures to ensure effective implementation.

On 29 October 2024, the Medical Devices Coordination Group (MDCG) published the document ‘MDCG 2024-13 Regulatory status of ethylene oxide (EtO) for sterilisation of medical devices’.

This document addresses the application of EtO during the manufacture of medical devices and in healthcare institutions to sterilise devices before or after use.

The latest guidance document MDCG 2022-5 Rev. 1 is a key resource for stakeholders working under Regulation (EU) 2017/745.

Developed by the Medical Devices Coordination Group (MDCG) and approved by representatives from all EU Member States, these guidelines aim to clarify the sometimes nuanced distinction between medical devices and medicinal products.