Important update on the Implementation of Class D oversight by EURLs: endorsement of Multi Services Agreement template
Recent advancements in the implementation of performance and batch verification for Class D in vitro diagnostic (IVD) devices under the In Vitro Diagnostic Regulation (IVDR) have been outlined in the latest Team-NB press release. This update highlights key improvements in ensuring compliance with stringent EU regulations for high-risk diagnostic devices, marking a significant step forward in the regulatory landscape for medical devices.
A major development in this process is the establishment of the Multi-Services Agreement (MSA), which provides a standardized approach for Notified Bodies (NBs) and European Reference Laboratories (EURLs) to verify compliance with the IVDR. The MSA ensures that these entities follow harmonized procedures, streamlining oversight processes for Class D devices, which are among the highest risk in the IVD category. This harmonization improves the efficiency and reliability of verification activities, directly impacting manufacturers' ability to meet regulatory requirements.
Additionally, the implementation of harmonized workflows under the MSA accelerates the transition to full IVDR compliance. With these streamlined procedures, manufacturers can expect faster approvals and certification of their high-risk IVD devices, facilitating their entry into the market. The alignment with EU regulations (EU) 2022/944, 2022/945, and 2023/2713 ensures that the processes meet the latest standards and are in line with EU's evolving regulatory framework for medical devices.
This development represents a crucial step in the EU's commitment to improving the safety and efficacy of IVDs, particularly for high-risk devices, which are critical for patient outcomes. With these updated procedures in place, manufacturers can expect more efficient oversight, leading to faster access to the market for their Class D devices while maintaining compliance with rigorous regulatory standards.
