Bringing a new IVD medical device to the market is a challenge–performance evaluation is key to demonstrate the product safety and performance as well as its value to the patient. For new class D IVDs (except for those for which common specifications already exist, or if other devices of that type have been previously certified) expert panels are consulted and provide views based on their Performance Evaluation Reports (PERs).
This process is called Performance Evaluation Consultation Procedure (PEPC). For the devices within the scope of this type of consultation, the Notified Body (NB) contacts the applicable expert panel, who reviews the PER and provides a view within 60 days. This expert panel view is not binding, but the NB is expected to give it due consideration when taking the decision on whether a device is ready to be certified or not.
As of June 2025, 21 views have been issued, most of them (86%) discussing PER flaws. Upon their review, one can extract the most commended aspects of PERs, as well as their most repeated drawbacks.
1. Positive PER Feedback
Some of the positive comments that are repeated through several expert panel views have to do with having a clear document structure and being able to easily identify data sources supporting compliance with each IVDR requirement. These two aspects, although mentioned in the context of the PER, are applicable to all technical documentation. Clarity and traceability facilitate the work of the reviewer and are key to enabling a complete evaluation.
Completeness of data (covering all specimen types, genetic variants, or other variables appearing in the IFU) is another positive note repeated across several expert panel views.
2. Common PER Flaws
As some may expect, several weaknesses identified in the reviewed PERs have to do with incomplete information. The majority of flaws highlighted by the experts have to do with one of four areas:
- Incomplete state of the art (SOTA)
- Lack of sufficient follow-up activities during the post-market phase (insufficient PMPF)
- Issues with the IFU (including incomplete sections, or misalignment between the IFU and other parts of the technical documentation)
- Gaps in the validation of the IVD medical device
The table below gives an overview of the flaws, taking into account the expert panel’s recommendations to address them.
| Common flaws | Recommendations |
| Incomplete SOTA | Add EU context: E.g. EU blood safety regulations explain benefits in EU setting where prevalence is low (e.g. risks of false positives and benefits for screening tests). Alternatives: Discuss other molecular tests or other platforms in use, benchmark vs alternatives, consider each type of specimen. Guidelines: Ensure they are included and referenced. Literature: Ensure it is recent, that it covers all specimen types, and all alternatives. |
| Insufficient PMPF | In cases of high mutation: Ensure there is a plan for detection of new variants AND a plan for communication to healthcare professionals and relevant stakeholders if new mutations are not covered by the device. Discuss performance over time. In cases of low prevalence where limited positive cases were identified in the pre-market phase–> ensure there is a plan to continue the evaluation with the addition of additional data collected during the PMS phase. |
| Misaligned or Incomplete IFU | Level of detail and limitations: Type of population tested (e.g. robustness tested in Caucasian only, limited suitability for immunocompromised patients), user information (e.g. not just “Professional use only.”, but a description of the type of professionals and their required training). Pool size: Indicate whether the device is for single sample or pooled samples. In cases of pooled samples, indicate what is the maximum pool number or, if unknown, at least indicate the maximum pool which has been validated. For high mutation targets: Include the target genes of each virus. If applicable, include CLSI reference values. |
| Incomplete Validation | Generalizability: If extrapolations are done between specimen types, single patient/pool, asymptomatic/symptomatic, early/late stage disease, over time, etc., ensure that a solid rationale is provided. Adequacy of the testing environment: EU usability if reason to consider it is different from other regions, environment considerations (e.g. stability of sample tested during a certain time and temperature reflective of day-to-day practice). Completeness: Ensure covering all parts of applicable guidelines. Sample size: Consider that adjustments may be needed when samples are close to the level of detection. Revise that all claims are covered. |
3. Applicability to Non-Class D IVDs
PECP is not applicable to class A, B or C IVDs, and it only applies to a subset of class D IVDs. The key takeaways extracted above derive from the expert panel views of novel class D devices, and some are device-specific (e.g., those considering low prevalence or high mutation).
Nevertheless, the general considerations of completeness of information, traceability, and ensuring alignment between different parts of the technical documentation are applicable to any IVD and should be useful to all manufacturers willing to have a well-rounded and compliant performance evaluation.
Frequently Asked Questions (FAQ)
Are the expert panel views published and, if so, where can I read them?
Expert panel views are public. The original documents of all IVD views provided under the PECP can be consulted online, in the European Commission webpage: List of views provided and ongoing consultations under the PECP – European Commission
Similarly, for medical devices, the expert panel opinions that stem out of the Clinical Evaluation Consultation Procedure (CECP) are also public: List of opinions provided under the CECP – European Commission
How do I know if an IVD is novel enough to need expert panel consultation?
In terms of novelty, the IVDR specifies that the expert panel consultation is only applicable if it is “the first certification for that type of device” (IVDR article 48(6)) and “there is no similar device on the market having the same intended purpose and based on similar technology” (IVDR recital 53).
MDCG 2021-22 provides some additional information on what needs to be considered when assessing if a device is of the same type.
With regards to the intended purpose, the following are considered:
- What is detected/measured
- Device function (screening, monitoring, diagnostic, etc.)
- Specific disorder, condition, or risk factor of interest
- Whether it is automated
- Whether it is qualitative, semi-quantitative or quantitative
- Type of specimen
- Testing population
- Intended user
With regards to technology, consider the:
- Principle of the assay
- Mode of operation of the device
To verify if a similar device has previously undergone expert panel consultation, one can consult the previous PECP views, which are public.
Who are the members of the expert panels?
The members of the expert panels are leaders in their therapeutic fields, appointed by the European Commission. Prior to their appointment to an expert panel, candidates must submit a declaration of interest, confidentiality obligations, and professional commitment. They are also expected to promptly update their declarations whenever there is a change in their professional circumstances, ensuring continued transparency and integrity.
Experts are either assigned to one of twelve specialized panels or listed in a central registry of available experts, based on their scientific and technical qualifications.
In the IVD therapeutic area, there are currently 22 experts from different geographies and backgrounds. The names of the experts can be consulted on the website of the European Commission.
How often should I update the literature review to ensure it is current?
The literature review feeds into several documents, including the PER and, for devices that are already CE-marked, also the PMPF report. In addition, relevant risks identified in the literature need to be considered for updates of risk management.
Literature search is often updated at the same time as the updated PER and the PMPF report. The frequency is determined by the risk of the device. At a minimum, per IVDR article 56 (6), the PER and associated documents must be updated annually for class C and D IVDs, and as necessary based on the post-market information for class A and B.
The above is the minimum frequency, but if any ongoing post-market activities shed light on any novelty in the field that may impact the state of the art or challenges the literature findings from the previous evaluation, then it is recommended to take action and do an earlier update of the literature, PER, and PMPF report.
