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The medical device industry is constantly evolving, and recently, the European Commission has introduced significant amendments to the transitional provisions of the In Vitro Diagnostic Regulation (IVDR) for certain legacy in vitro diagnostic medical devices. These amendments have a considerable impact on how manufacturers and distributors must handle their legacy products in the European market. What is the IVDR? The IVDR (Regulation (EU) 2017/746) is a regulation governing in vitro diagnostic medical devices in the European Union. It came into force in May 2017, with a transition period culminating in May 2022. This regulation replaced the In Vitro Diagnostic Directive (IVDD), introducing stricter requirements to ensure the safety and efficacy of these devices. Main Changes to the Transitional Provisions The European Commission has recognized the need to adjust the transitional provisions for certain legacy devices, those that were certified under the previous IVDD and are still on the market. The main changes are:
- Extended Transition Deadlines: Transition deadlines have been extended for some legacy devices, allowing manufacturers more time to comply with the new IVDR requirements. This is crucial to ensure a smooth transition and avoid disruptions in the supply of essential products.
- Compliance Reassessment: Legacy devices must undergo a compliance reassessment under IVDR standards. This involves a thorough review of technical documentation and clinical evaluations to ensure that they meet the new safety and efficacy standards.
- Post-Marketing Surveillance: Post-marketing surveillance requirements have been strengthened for legacy devices. Manufacturers will be required to implement robust surveillance and incident reporting systems to identify and mitigate any risks associated with the continued use of these devices.
- Updated Technical Documentation: Manufacturers are required to update the technical documentation of their legacy devices, ensuring that all tests, evaluations and clinical data comply with the standards set forth in the IVDR.
Industry adaptation With this new Regulation, the European Union aims to help manufacturers and distributors of in vitro diagnostic medical devices in their adaptation and transition to the new European regulatory framework. It is also an opportunity to further enhance the quality, safety and competitiveness of these products. Thus, the European Union is committed to a predictable and orderly transition that facilitates compliance with the new requirements. This is essential to maintain market confidence and ensure the continued supply of high quality medical devices for all European citizens. CQS remains committed to guiding our customers through these changes, and we will continue to publish the most relevant regulatory developments in the industry.