IVDR: Clinical Evidence Requirements for Manufacturers

Article 56 (1) of the Regulation on in vitro diagnostic medical devices states that manufacturers must specify and justify the level of clinical evidence in view of the characteristics of the device and its intended purpose. To achieve this goal, manufactures must focus not only on clinical evidence but also on the continuous process of performance evaluation of their IVDs.

Clinical evidence for IVDs

Clinical evidence for IVDs is established through the collection of data as a result of a performance evaluation. Performance evaluation covers the assessment and analysis of data to establish and verify the scientific validity, analytical performance and, where applicable, clinical performance of an IVD.

Article 2 (36) of Regulation (EU) 2017/746, underlines that clinical evidence should be based on a sufficient amount and quality of data in order to allow a qualified assessment of safety and clinical benefits of IVDs when used as intended.

Clinical benefit for IVDs is fundamentally different from that which applies in the case of pharmaceuticals or of therapeutic medical devices since the benefit of IVDs lies in providing accurate medical information on patients, where appropriate, assessed against medical information obtained through the use of other diagnostic options and technologies, whereas the final clinical outcome for the patient is dependent on further diagnostic and/or therapeutic options which could be available.

Clinical evidence may include data from devices deemed as equivalent to the device under assessment. The manufacturers’ QMS defines the managing of equivalence along with a justification for the application of such equivalence.

The performance evaluation begins with the establishment of the Performance Evaluation Plan in accordance with Annex XIII. The manufacturer should compile evidence, determine the benefit-risk and document the performance evaluation and its output in the Performance Evaluation Report.

The risk management system should be carefully aligned with and reflected in the performance evaluation process of the IVD, considering the clinical risks to be addressed as part of the performance evaluation, performance studies, and post-market performance follow-up(s)

Performance evaluation

Performance evaluation should be regarded as a continuous process aiming at maintaining the clinical evidence supporting the intended purpose of devices. Therefore, the IVDR contemplates a device’s lifecycle approach, whereby clinical evidence is updated continuously.  The safety, effectiveness, and performance of the IVD is maintained by data that is actively and continuously monitored and collected by the manufacturer. Such data may include developments in the state-of-the-art, post-market information such as complaints, PMPF data, direct end-user feedback or newly published research, guidelines, harmonised standards.

In the context of continuous update of the performance evaluation, planning of thorough post-market surveillance activities are critical to detect signals and ensure continued performance (e.g. monitor for possible shifts that may signify the emergence of mutated strains not detected by a specific assay).

Manufacturers are expected to review and assess scientific developments and information of the devices on a regular basis as part of post-market surveillance activities. In this context, scientific developments, and improvements in state-of-the-art should be reviewed and assessed by the manufacturer on a regular basis as part of their continuous and pro-active post-market surveillance activities.

Are you a manufacturer planning on placing your IVDs in the EU market? Do you have difficulties in complying with the IVD Regulation?

Obelis can assist you in achieving compliance with the IVDR’s requirements in the most successful way thanks to its 30-year-experience in regulatory affairs!

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Sofia Ingrande

Regulatory Affairs Department



MDCG (2022) Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs). Retrieved on 27 January 2022 from https://ec.europa.eu/health/latest-updates/mdcg-2022-2-guidance-general-principles-clinical-evidence-vitro-diagnostic-medical-devices-ivds-2022-01-27_en

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