The next key regulatory milestone for manufacturers with products on the European market is the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). A critical stage of IVDR planning is for manufacturers to assess whether they have enough clinical and performance data that meets notified body expectations.

Without this key intelligence, they may leave themselves insufficient time to source the clinical evidence they need – we are already seeing too many IVD manufacturers falling into this trap. Ensuring that clinical evidence stands up to notified body scrutiny is one of the biggest challenges for IVDR compliance.

In this technical brief, we’ll take a brief look at the requirements, and end with a checklist that manufacturers can use to begin assessment of their clinical data.

Defining clinical and performance data

Firstly, what is meant by ‘clinical’ and ‘performance’ data? The two terms are often used interchangeably when referring to clinical evidence, making it difficult to distinguish what falls under each umbrella.

Performance data normally refers to analytical and clinical assay parameters, such as accuracy, diagnostic specificity or sensitivity for example.

Clinical evidence is an all-encompassing term that covers scientific validity, analytical and clinical performance. It contains all relevant study data, literature and other sources of technical information, and the analysis and conclusions of the performance evaluation process. The goal of clinical evidence is to scientifically demonstrate, by reference to state of the art in medicine, that the device is safe and that the intended clinical benefit is achieved.

Gathering sufficient clinical evidence

Manufacturers must first determine their device classification, to then identify the level of clinical evidence needed. The IVDR has four possible types of classification: Class A is for low-risk products and class D is for products with the highest risk.

Under this new classification, the risk to individual and public health increases with each class, and the corresponding conformity assessment requirements also increase. The depth of performance evaluation – and the level of notified body scrutiny – is therefore proportional to the device risk, novelty, intended purpose, and specific claims.

Class A devices placed on the market in sterile condition require a notified body conformity assessment which is limited to the aspects concerning sterility, whereas non-sterile Class As do not undergo notified body review. However, manufacturers still need to create Performance Evaluation Reports for all devices, irrespective of classification. All other classes are subject to notified body assessment.

Compiling a Performance Evaluation Report

The IVDR states that clinical evidence must demonstrate a continuous process of performance evaluation and must support the intended purpose of the device as stated by the manufacturer. Article 56 of the IVDR states that, “A performance evaluation shall follow a defined and methodologically sound procedure for the demonstration of the following, in accordance with this Article and with Part A of Annex XIII: (a) scientific validity; (b) analytical performance; (c) clinical performance” [1] .

Once a manufacturer is satisfied they have all the data needed to support compliance with the IVDR, they must prepare a scientific validity report, analytical performance report and clinical performance report. These are part of the overall Performance Evaluation Report (PER) and will be assessed together to demonstrate clinical evidence for the device. Manufacturers may be asked to provide supporting data as well, so they must ensure that it is readily available.

Crucially, they must be able to provide justification on the relevance of the data being submitted. Where devices have been through several iterations, for instance, manufacturers will need to carefully review whether their data is appropriate for the latest version of the product.

A checklist for clinical evidence assessment

To get manufacturers started with their clinical evidence assessment, we’ve put together a checklist of questions below.

For more support on carrying out gap assessments, identifying and classifying IVDs, and developing performance evaluation plans and reports, book a consultation with our expert team. For a deeper dive into this topic, download our white paper "Performance Data and EU IVDR: Improving operational efficiencies through compliance".

Assess your clinical data

  • How up-to-date is your technical documentation?
  • Does it satisfy all of the requirements per Annex XIII?
  • If you have not performed a clinical performance study, can you properly justify your position for relying on other sources of clinical performance data?
  • How does your device perform against recognised standards?
  • Has your data ever been independently reviewed? Will it stand up to Notified Body scrutiny?
  • Does your clinical evidence, including for legacy devices, address the state of the art today with appropriate references to standards, common specifications, clinical guidelines?
  • Does your clinical performance data support the intended user setting? Have you considered different requirements for lay users, near patient testing environments and professional laboratory users?

[1] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Download the RQM+ white paper: Performance Data & EU IVDR

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