Explore the latest advancements in IVDR compliance for Class D IVDs, including the Multi-Services Agreement (MSA) for harmonized verification by Notified Bodies and EURLs. Learn how streamlined processes enable faster approvals and market access.

The European Commission's Regulation (EU) 2024/1860 introduces critical updates to EU medical device regulations, including the gradual implementation of Eudamed, a central database to enhance the traceability and safety of medical devices and IVDs. These updates aim to ensure supply chain continuity by mandating manufacturers and suppliers to promptly notify healthcare professionals and authorities about any supply disruptions or discontinuations. Transitional provisions for certain IVDs provide a smoother compliance path under the amended MDR and IVDR frameworks, reducing the risk of device shortages while maintaining healthcare product availability and improving market transparency.

The recently released MDCG 2024-16 introduces the Manufacturer’s Information Form, a critical step toward enhancing transparency and communication regarding medical device supply interruptions and discontinuations in the European market. This form ensures that manufacturers notify authorities, healthcare professionals, and other stakeholders about potential supply issues, supporting patient safety and regulatory compliance. By enabling timely notifications, it allows healthcare providers and distributors to adapt their supply chains and maintain access to essential medical devices and IVDs. These updates strengthen the EU’s medical device regulatory framework, emphasizing efficiency and safety while mitigating risks of device shortages.

The FDA’s guidance on Predetermined Change Control Plans (PCCP) offers clear recommendations for integrating AI-enabled device software functions into the medical device industry. This framework allows manufacturers to implement pre-approved modifications to their AI-driven software without requiring new marketing submissions, streamlining the regulatory process. By addressing the unique needs of AI algorithms, such as ongoing updates and improvements, the PCCP ensures that these advancements maintain safety, efficacy, and compliance. The FDA emphasizes transparency and monitoring, enabling medical devices to evolve while adhering to rigorous regulatory standards. This innovative approach fosters AI innovation, empowering companies to deploy responsive and adaptive AI-enabled medical technologies that enhance patient care and outcomes.

The MDCG 2024-15 guidance provides crucial instructions on managing clinical investigation reports and plain-language summaries in the absence of EUDAMED, the European database for medical devices. This interim solution ensures compliance with MDR Article 77, emphasizing the importance of transparency and public accountability. Sponsors must submit clinical reports within one year of the investigation's conclusion or three months for early terminations, with public access aligning with device registration or defaulting to one year after submission. To address the gap left by EUDAMED, national procedures and the CIRCABC directory will temporarily facilitate the sharing of these documents. By adapting to these measures, stakeholders can maintain regulatory compliance and foster confidence in the medical device industry, aligning with evolving EU regulations.

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.