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EU IVDR Performance Evaluation Plan and Report Consultants

The European In Vitro Diagnostic Regulation (2017/746) imposes tough new requirements on IVD manufacturers. While performance evaluation was always required under the IVDD, your plan and data will now be scrutinized by a Notified Body. An important aspect of IVDR compliance is the Performance Evaluation Report (PER) which documents the scientific validity, analytical performance and clinical performance supporting your IVD's intended purpose.



Start with a Gap Assessment of Your Current IVD Performance Data

Many IVD manufacturers may not be able to produce the clinical data required by the IVDR. We can provide end-to-end support for helping you meet EU IVDR performance evaluation requirements:

  • Performance Evaluation Plan - We help you develop a structured PEP outlining the clinical evidence generation approach based on your IVD's risk class, intended use, technology, and other factors.
  • Data Analysis - Our experts can systematically review and appraise the quality and adequacy of your existing data from literature, previous performance evaluation studies, or new studies. We identify any gaps that require generating additional evidence.
  • Performance Evaluation Report Development - We compile, document and analyze all your performance data into a PER that meets IVDR expectations for content, structure and level of detail.
  • QMS Linkages - We check your QMS clearly to ensure references to performance evaluation planning, methodology and analysis. We also ensure that performance evaluation links appropriately with other processes such as risk management and PMS.
  • Ongoing Updates - We can help update your PER over the product lifecycle based on design changes, post-market surveillance insights and new clinical evidence as part of post-market performance follow-up.

IVD Performance Evaluation Services

We have completed hundreds of technical documentation evaluations for clients and will examine all of your existing data (including post-market data) and make specific recommendations on gaps that need to be closed. We can be as involved in that process as you like, supplementing your internal efforts or taking a lead role on specific compliance projects. This may include:

  • IVDR performance evaluation transition strategy - If you have numerous IVDs that will be transitioning from IVDD to the IVDR, we can help you prioritize and map out the transition process while being mindful of your investment and availability of internal resources.
  • Gap analysis of existing IVD performance evaluation plans and reports - We will outline areas of concern, and/or additional clinical/scientific/analytical evidence that may be required. We can assist in rectifying issues that are uncovered or your team can do this.
  • Preparation of new IVD performance evaluation reports - If you do not have the bandwidth or in-house expertise to create a new PER, our IVD team stands ready to assist.

Let Us Help You Take the Next Step Toward IVDR Compliance

Our process ensures your PER provides robust clinical evidence demonstrating the IVD's safety, performance and benefit-risk ratio as required for regulatory compliance. With our support, you can confidently demonstrate conformity to EU requirements during your next Notified Body audit. Contact us today to discuss how we can assist you in making a seamless transition to the IVDR.

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