Overwhelmed by all the challenges presented by the IVDR, such as new risk classification rules, expanded clinical evidence requirements or need for notified body approval where none was required previously? Experience with the implementation of MDR for medical devices can help frame the potential impact of IVDR on your new or legacy IVD device!
Similar to how the MDR Clinical Evaluation Report (CER) documents the clinical evaluation of a medical device, the IVDR Performance Evaluation Report (PER) documents the performance evaluation of an IVD device.
Additionally, ‘clinical evidence’ as defined by MDR Article 2(51) looks identical to IVDR Article 2(36), albeit the latter is based on performance evaluation results. From IVDR Article 56, we see:
Similar to the clinical evaluation under MDR, the level of clinical evidence needed for your IVD device will depend on device classification, and moreover, the depth of the performance evaluation required for your IVD device will mirror its risk, intended purpose, novelty and clinical claims, all of which fall under the scrutiny of a notified body (except IVDR Class A non sterile).
As of 27 May 2022, the in vitro device regulation (IVDR) took effect for in vitro diagnostic medical devices sold in the EU. How familiar are you with the three pillars of performance evaluation for your IVD device? Do you know how these pillars are used to establish the clinical evidence?
The three pillars of the performance evaluation report are the scientific validity report, an analytical performance report, and the clinical performance report with an assessment of the reports allowing demonstration of the clinical evidence. The performance evaluation is a continuous process by which the three pillars are assessed and analyzed for the device’s intended purpose. The manufacturer is to document how the performance evaluation will be performed in a performance evaluation plan.
The scientific validity report shall demonstrate and document the scientific validity of the analyte or marker. This may be from relevant information on the scientific validity of devices measuring the same analyte or marker, scientific peer-reviewed literature, consensus expert opinions/positions from relevant professional associations, results from proof-of-concept studies, or results from clinical performance studies.
The analytical performance report may include items (from Annex I Section 9.1) such as analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and quantitation, measuring range, linearity, cut-off, including determination of appropriate criteria for specimen collection and handling and control of known relevant endogenous and exogenous interference, and cross-reactions.
The clinical performance report shall include clinical performance such as (from Annex I Section 9.1) diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, likelihood ratio, and expected values in normal and affected populations. Evidence for clinical performance may be based on clinical performance studies, scientific peer-reviewed articles, or published experience gained by routine diagnostic testing.
If you’re looking for medical writing support for your in vitro diagnostic medical devices, let’s talk! We, at Bannick LLC, a primary device group, partner with companies across the globe to certify the highest quality products in patient care. Looking forward to talking to you!