EU Launches Public Consultation on Medical Devices and In Vitro Diagnostics Regulations
The EU medical device and IVD regulations are undergoing a comprehensive evaluation through the European Commission public consultation, open until March 21, 2025. This initiative aims to assess the effectiveness of the current medical device regulatory framework in ensuring safety and innovation while addressing key challenges faced by SMEs and fostering improved market access. Stakeholders are encouraged to share insights on critical issues, such as the availability of orphan devices, the impact of IVD regulations, and the need for streamlined processes to support a competitive and evolving healthcare innovation landscape in the EU.
MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices
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.
MDCG 2024-15 - Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED
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.