In Chapter VI, clinical evidence, performance evaluation and performance studies are regulated in Articles 56 to 77. Post-marketing performance evaluation, performance studies and follow-up are regulated in Annex XIII:
Part A refers to performance evaluation and clinical studies.
Part B refers to post-marketing performance follow-up.
Art. 56 (3) of the IVDR defines the process of a performance evaluation according to Annex XIII, Part A, para. 1. The performance evaluation of a device is an ongoing process by which data are evaluated and analyzed to demonstrate the scientific validity, analytical performance, and clinical performance of that device with respect to its intended purpose as stated by the manufacturer.
The following is regulated:
- Documentation of performance evaluation and clinical evidence in Art. 57 (4)
- Performance study requirements in Art. 57 to 77.
- Content of the performance evaluation plan is regulated in Annex XIII (A.1.1).
- Systematic evaluation of the scientific literature in Annex XIII (A.1.2), after finding the data and subsequent evaluation, unresolved questions and data gaps are to be identified. If necessary, new or additional data must then be generated.
- Analytical performance in Annex XIII (A.1.2.2) and Clinical & Laboratory Standards Institute (CLSI) standards and Annex I (9.1a).
- Evidence of clinical performance according to Annex XIII (A.1.2.3) based on the clinical performance study (Annex XIII (2), scientific literature, and published experience gained from routine diagnostic testing.
- Clinical performance characteristics in Annex I (9.1b): diagnostic sensitivity and specificity, positive and negative predictive value, Likelihood ratio, and expected values in affected and unaffected populations (see also MedTech Europe - Clinical Evidence, Chapters 2,4 and 5).
- Performance studies in relation to products that may bear the CE marking in Art. 70
- Conduct of a performance study in Article 68, (1-6)
- Purpose of a clinical performance study in Annex XIII, Part A Section 2
- Performance studies in which residual samples are used in (73), according to MPDG Art 3 (4e): residual material of human bodily substances that originates from a medically indicated collection
- Clinical performance study report in Annex XIII (A.2.3.3 and ISO 20916:2019, Chapter 8.2. and Annex D.
- Additional requirements for certain performance studies (e.g., increased risks, interventional, surgical) in Art. 58 (1) - (2), approval requirement, all requirements under 58 (5) met, recording and reporting; exceptions to this are therapy-accompanying diagnostics with residual samples; see also MPDG Ch. 4 and Art. 3 (from 26.5.2022, until then MPG)
- Conditions additional requirements in Art. 58 (5a-f): approval, no statement of disapproval by appointed independent ethics committee, establishment of sponsor in EU, protection of vulnerable populations, expected benefits legally ready risks and harms, informed consent.
- Electronic system for performance studies subject to approval in Art. 69 (1).
- Interventional clinical performance studies and certain other Annex XIV performance studies, ONLY if analysis performance already established.
- Application for approval in Annex XIV I. (1) - (4): application form, investigator's manual (see a ISO 20916:2019, chap. 5.4 and Annex C), clinical performance study plan (Annex XIII (2) and (3)) and other information.
- Further obligations of the sponsor in Annex XIV II. (1) - (5)