Tuesday, April 16, 2024

EU Acts to Prevent Medical Devices Shortages with New Regulations and Extended IVD Compliance Periods

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The European Union Council has introduced new measures aimed at preventing medical devices shortages, enhancing transparency, and improving access to information. These regulations, approved by representatives of EU member states, involve amendments to legislation concerning medical devices, including in-vitro diagnostics (IVDs). Key changes include extending the transition period for certain high-risk IVDs, implementing a phased rollout of the electronic European database on medical devices (EUDAMED), and mandating manufacturers to report potential critical IVDs and medical devices shortages.

The extension of the transition period for certain in-vitro diagnostics stems from the implementation of the In Vitro Diagnostic Medical Device Regulation (IVDR) in 2017, which was introduced alongside the Medical Devices Regulation (MDR). These regulations were aimed at modernizing the regulatory framework governing IVDs within the European Union, reflecting advancements in medical technology and the evolving landscape of diagnostic testing.

The IVDR brought about significant changes to the requirements for IVD manufacturers, imposing stricter standards for safety, efficacy, and quality assurance. Compliance with these new regulations necessitated a considerable investment of scientific, technical, and regulatory expertise from manufacturers. However, despite efforts to meet the new requirements, many IVDs have faced challenges in achieving full compliance within the designated timeframe.

Extended Deadlines for IVD Manufacturers to Meet New Regulatory Standards

The initial transition period provided to manufacturers to adapt to the IVDR requirements posed a significant deadline for ensuring compliance. Failure to meet these requirements within the stipulated timeframe could potentially result in the removal of non-compliant IVDs from the market, posing risks to patient care and diagnostic capabilities.

Recognizing the complexity of the regulatory changes and the challenges faced by manufacturers in meeting compliance deadlines, the recent revisions aim to address these concerns by extending the transition period for certain categories of IVDs. By granting additional time for manufacturers to achieve compliance, these revisions aim to alleviate the pressure and facilitate a smoother transition to the new regulatory framework.

The extension of the transition period provides manufacturers with the opportunity to refine their processes, address any outstanding compliance issues, and ensure that their products meet the necessary standards for safety and performance. It also allows regulatory authorities to collaborate with manufacturers, providing guidance and support to facilitate the compliance process.

The extension of the transition period for specific IVDs reflects a pragmatic approach to regulatory oversight, balancing the need for stringent standards with the practical challenges faced by manufacturers in meeting compliance requirements. By providing a more flexible timeline for adaptation, these revisions aim to safeguard patient safety, preserve access to essential diagnostic technologies, and promote innovation within the IVD industry.

Medical Devices Shortages

EU Enhances Medical Device Rules: EUDAMED Early Use & Medical Devices Shortages Reporting

Another aspect of the regulations focuses on the electronic European database on medical devices (EUDAMED), established to enhance transparency and access to information about medical devices available in the European market. While manufacturers were initially permitted to delay registration until all modules of EUDAMED were operational, the completion of these modules is expected to be delayed until late 2027. To expedite the registration process, the council now requires manufacturers to provide product information using the available modules, with this requirement slated to take effect in late 2025.

Additionally, the new measures introduce an obligation for manufacturers to notify relevant authorities, healthcare institutions, professionals, and supply chain operators about any anticipated interruptions in the availability of critical medical devices or in-vitro diagnostics. This proactive reporting is intended to mitigate the impact of potential medical devices shortages on patient care and public health.

The agreed-upon revisions signify a proactive approach by the EU Council to address challenges in the medical device regulatory landscape, ensuring continued access to essential healthcare products while promoting safety and transparency. Once formally adopted by the European Parliament and the EU Council following linguistic review, these measures are poised to have a significant impact on the regulation and oversight of medical devices across the European Union.


Resource: MDDİ online, February 27, 2024

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