IVDR transition period and how it affects your compliance strategy
The IVDR Regulations and the Changing Landscape:
The In Vitro Diagnostic Regulation (IVDR), as outlined in Regulation (EU) 2017/746, became fully applicable on May 26, 2022. Companies engaged in the manufacturing of products for the IVDR market were expected to be well prepared by this date. However, a series of factors compelled regulatory authorities to reconsider and extend the transition period.
Understanding the Amendment to the IVDR:
In March 2023, Regulation (EU) 2023/607 ushered in significant changes to the In Vitro Diagnostic Regulation (IVDR). This amendment addressed the transition periods for products that had obtained the CE mark under the In Vitro Diagnostic Directive (IVDD). These products, often referred to as legacy devices, can now be placed on the market until various deadlines—May 26 of 2025, 2026, and 2027, depending on the risk classification of the product under the IVDR.
Don't Delay Your IVDR Transition Plan - Connect with Repado Today!
While the extension of the IVDR transition period may seem like an opportunity to breathe, it's important to recognize that this should not deter medical device manufacturers from their established compliance strategy. There are two critical reasons for this:
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Limited Product Changes: During the transition period, manufacturers are generally not allowed to make significant changes to their products. This means that your products must comply with the existing IVDR regulations during this phase
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Challenges in the Review Process: It's worth noting that the scarcity of IVDR Notified Bodies and the potentially lengthy review process can pose risks to your company's transition plan. Delaying action may hinder your ability to secure the necessary approvals and certifications within the desired timeframe
Consult with Repado for Informed Guidance
With the complex and evolving regulatory landscape, it's essential to stay on top of your IVDR transition strategy. Repado team is here to provide expert guidance and support during this critical period. Reach out to us for a consultation call at info@repado.com.
Our insights can help you navigate the challenges of the IVDR transition period, ensuring that your compliance strategy remains on track and in line with the evolving regulatory framework. Don't hesitate to connect with us and let us be your trusted partner as you navigate this ever-changing landscape.
