Planning for Performance Evaluation Under the IVDR

Even for those that have prepared a performance evaluation summary document for an IVD CE marked under the IVDD or clinical evaluation documentation in accordance with MDD or MDR requirements, planning for performance evaluation under the IVDR can be a daunting task. 

Steps that Manufacturers can take to prepare for performance evaluation under the IVDR

While the IVDR establishes the minimum content for performance evaluation plans and (limited) guidance is available in MDCG 2022-2, there are several steps that IVD manufacturers can take to prepare for performance evaluation, including the following: 

1. Identify and address knowledge/resource gaps 

While clinical expertise and judgment are necessary at every step of the performance evaluation, just as is the case for closely linked processes such as risk management, a multidisciplinary approach is typically preferred. In particular, representatives from your regulatory, quality, and design teams should be involved to some extent in performance evaluation. Personnel with relevant scientific backgrounds are highly valued for this process as they may contribute to critical activities such as literature searches. In many cases, manufacturers will need to reach out to external resources with a combination of regulatory and design experience to provide training or consulting support to address knowledge/resource gaps. 

2. Establish the performance evaluation and associated processes

Under the general obligations of manufacturers established under the IVDR, Article 8(f) establishes that their quality management system (QMS) shall address performance evaluation and several other aspects including a strategy for regulatory compliance. In the case of performance evaluation, this means putting in place procedures outlining the organization’s approach to performance evaluation, as well as the relevant template forms to be used for all performance evaluation outputs (i.e. Performance Evaluation Plan (PEP), Scientific Validity Report (SVR), Analytical Performance Report (APR), Clinical Performance Report (CPR), and Performance Evaluation Report (PER)). Additionally, procedures shall be generated that provide as well as for supporting template forms such as Literature Search and Review Protocols & Reports.

Just as is the case for clinical evaluation under the MDR, one of the critical supporting principles of the IVDR is the inter-relationship of performance evaluation with other QMS processes, including: 

• •  Design and Development, including the development of labeling and realization of performance evaluation studies
  •  Risk Management
  •  Post-Market Surveillance (PMS) & Post-Market Performance Follow-up (PMPF)

The QMS procedures establishing these processes will either need to be created or subject to revision and relationships established with performance evaluation under the IVDR. 

3. Prepare or review/revise “supporting” documentation/labeling 

Once the respective processes have been established, it’s time to prepare or review/revise the documentation/labeling related to these processes for the device in question. Certainly in the case of risk management, if manufacturers have not already done so, they should revise their risk management files for conformity with the relevant standard harmonized under the IVDR, i.e. EN ISO 14971:2019. Labeling, in particular, is of critical importance to performance evaluation under the IVDR, as it is directly related to several of the minimum PEP content requirements (e.g., intended purpose/use, device analyte/marker, specific analytical and/or clinical performance characteristics, etc.). These will need to be aligned and support the performance evaluation documentation. 

4. Identify and prepare the necessary level of clinical evidence 

The IVDR mandates that manufacturers specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant GSPR. For new device manufacturers, this involves determining the type of clinical evidence necessary for the device based on its characteristics which will subsequently drive the scope and level of evidence necessary in the SVR, APR, and CPR. For legacy devices (those already on the market under the IVDD), manufacturers should re-appraise the clinical evidence on file and determine whether it is adequate for IVDR conformity. This also includes the identification of those GSPR Under Annex I, Sections 1-9 that are applicable to the device and relevant to the supporting evidence. At the completion of this stage, you should have a draft SVR, APR, and CPR ready for approval once the PEP has been approved. 

5. PEP / PER compilation 

You’re now ready to compile the PEP / PER using the resources, tools, processes, and forms that you’ve established. Remember that as the IVDR is based on lifecycle device management, once your initial PEP / PER is completed (irrespective of the schedule established for the next PER update), you’ll need to periodically review the relevant PMS and/or PMPF data to determine whether PER conclusions continue to remain valid or an unscheduled update is warranted. Furthermore, your ongoing regulatory intelligence process should be capable of identifying any relevant changes to regulatory requirements under the IVDR or guidance that may impact the performance evaluation process. 

Learn more about IVDR performance evaluations with MedEnvoy

If you have any additional questions regarding performance evaluation or require relevant training / and or consulting services, get in touch.  

Explore similar topics

• • Understanding the Specific Evaluation Documentation Required for IVD Performance Under Article 56 of the IVDR