Navigating the latest EU updates on medical device regulations, particularly for legacy in vitro diagnostics (IVDs), can be complex, but understanding these changes is essential for maintaining market access and compliance. Here’s what you need to know and how BSP Ltd. can support you through this transition.

Extended Timelines for Legacy IVDs: A Closer Look

The EU’s recent extension under Regulation 2024/1860 provides much-needed breathing room for manufacturers of legacy IVDs—those products previously certified under the older IVDD. These extensions are specifically designed to prevent shortages of critical devices while manufacturers transition to meet the newer, stricter IVDR standards.

Key Dates to Remember

1. Class D Devices: The highest-risk IVDs, such as those used in pathogen detection, must comply by 26 May 2025.

2. Class B and C Devices: These devices, representing a significant portion of diagnostics, have until 26 May 2026 to achieve compliance.

3. Class A Sterile Devices: These lower-risk devices are required to comply by 26 May 2027.

To qualify for these extensions, manufacturers must have submitted an application for IVDR certification and established a formal agreement with a notified body, which helps define the necessary steps to complete certification.

Why This Matters

This regulatory shift impacts not just compliance, but also the market stability of essential diagnostic devices across Europe. The goal is to mitigate supply interruptions while supporting a controlled transition, which is crucial for both healthcare providers and manufacturers.

How BSP Ltd. Can Help

At BSP Ltd., we specialise in guiding businesses of all sizes through the complexities of EU regulatory changes. Whether you’re a small enterprise or an established manufacturer, our team is ready to assist you in understanding these new timelines, setting up compliance strategies, and preparing documentation to meet notified body requirements.

For businesses navigating these updates for the first time, we’re offering a free initial consultation to assess your specific needs and develop a clear roadmap for achieving compliance. Reach out to BSP Ltd. to discuss how we can streamline this transition, saving you time, resources, and regulatory headaches.

With our expertise in EU medical device regulations, BSP Ltd. is here to help you stay compliant and competitive in a rapidly evolving regulatory landscape.