The Medical Device Coordination Group published the new guidance MDCG 2022-2 “Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)” on 27th January 2022.
The paper outlines general principles of clinical evidence and gives information about the performance evaluation process for in Vitro Diagnostic-Medical Devices under the IVDR (EU) 2017/746 Regulation.
General principles of clinical evidence
Before placing an in Vitro Diagnostic-Medical Device on the market, the Manufacturer needs to plan, carry out, and document a performance evaluation to scientifically prove that the product is safe, and that it can achieve the clinical benefits expected by the Manufacturer.
In particular, during the performance evaluation three principles that constitutes the clinical evidence are considered:
- Scientific validity, namely the association of an analyte physiological state or clinical condition.
- Analytical performances such as a device’s ability to correctly detect or measure a particular analyte.
- Clinical performance which is ability to yield results correlated with a particular clinical condition or a physiological/pathological process or state in accordance with the target population and intended user.
Performance evaluation process
Performance evaluation, run by the quality management system of the company, is a steady and ongoing process and needs to be performed during the entire life cycle of an in Vitro Diagnostic-Medical Device. It has to be an objective evaluation, considering favourable and unfavourable data, risk/benefit ratio, risk class, and the device’s itself intended purpose.
The general performance evaluation principles are laid down in Article 56 and Annex XIII, Part A-1 of the IVDR (EU) 2017/746 Regulation:
- Performance Evaluation Plan (PEP),
- Analysis, conclusions, and documentation (Performance Evaluation Report – PER),
- Ongoing updating and monitoring thought Post-Market Performance Follow-up (PMPF).
In order to guarantee IVD’s safety, it is important to constantly monitor scientific developments and possible changes, as any relevant new information could trigger re-evaluations of existing clinical evidence.
Clinical evidence and performance evaluation: how to deal with them?
Thema is here to support you! If you are an IVDs Manufacturer, Thema’s experts can assist and guide you step by step in clinical evidence and performance evaluation activities under the IVDR (EU) 2017/746 Regulation.