Ensuring a successful transition to IVDR requires efficiently tackling all the challenges imposed by the new regulation

IVDR Timelines and Requirements

The In Vitro Diagnostic Regulation (IVDR – EU 2017/746) provides a new classification system that determines the Conformity Assessment pathway based on the IVD risk class. As a result, most of the previously self-certified marketed and newly developed IVDs need to be assessed for the first time by Notified Bodies to remain in the market. However, the limited number of currently designated Notified Bodies combined with increased demand is making the CE marking process a real challenge.

Given this unprecedented situation, Regulation (EU) 2022/112 provides an extended transitional period, by which all IVDs need to undergo a new and complete Conformity Assessment, latest by May 2027 (depending on the product’s risk class).

In this regard, a deep understanding of the transition provisions is a must to set up a strategic roadmap specific to each IVD product.

Key Challenges for a Successful Transition to IVDR

Verification & Validation (V&V) and Risk Management

When determining the appropriate V&V activities for an IVD, it is highly recommended to identify the risks linked with the use, design and manufacturing of the device and the mitigations for these risks. The V&V activities should then focus on demonstrating that the IVD meets the requirements related to these risks and their mitigations. Finding a connection between V&V activities and device risks can be a daunting task.

Clinical Evidence and Performance Evaluation

With the implementation of the IVDR, a performance evaluation needs to be conducted to demonstrate a device’s performance and safety. This performance evaluation follows a defined Performance Evaluation Plan (PEP) and is documented within a Performance Evaluation Report (PER). Some manufacturers wonder about the clinical evidence data needed to support the performance and safety of the IVD, when used as intended.

Post-market Vigilance Activities

IVDR requires manufacturers to define a post-market surveillance (PMS) plan for collecting and assessing performance data from their devices. In addition, the post-market performance follow-up (PMPF) should confirm the safety, performance and scientific validity throughout the expected lifetime of the IVD, the product benefit-risk ratio, and any new emerging risks. Both PMS and PMPF requirements are applicable to all IVDs and despite understanding them, companies are often not fully prepared to comply with them.

How Medidee Supports your IVDR Transition Process

An effective IVDR transfer strategy often begins with an assessment of the existing Technical Documentation, regardless of its status of readiness. With our expertise and resources, we make the process easy for you by:

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Evaluating your Technical Documentation against IVDR Requirements but also considering our recent experience with Notified Bodies

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Assisting with subsequent updates through training, coaching, implementation or any combination of those

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Supporting you with the Performance Evaluation process: from updating PEP/PER to supporting with the design/conduct of clinical performance studies and definition of adequate PMS and PMPF plans/reports

Strategy Towards Results

Managing the new IVDR requirements can be challenging, particularly when dealing with large product portfolios.

Medidee’s IVDR experts collaborate with your team to design and implement a strategy that is tailored to your specific challenges and needs for a well-managed transition to IVDR.

Leveraging the experience gathered from frequent interactions with IVD manufacturers and from successfully managing countless IVDR transition processes, Medidee is uniquely positioned to offer the most effective strategy for success.

IVDR Strategy

Contact Medidee to discuss your needs