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The European Union’s Regulation 2017/247, commonly known as the In Vitro Diagnostic Regulation (IVDR), aims to enhance patient safety and to ensure the efficacy of in vitro diagnostic medical devices. Compared to its predecessor, the In Vitro Diagnostic Directive (IVDD), IVDR puts forward increased requirements and obligations for manufacturers, importers, and distributors alike. Central to the enhanced framework of the IVDR is the concept of clinical evidence.
A central pillar of the IVDR is the emphasis on clinical evidence. Clinical evidence is not just a mere formality or a checkbox to be ticked off. Let’s dive into the significance of clinical evidence in the context of the IVDR.
Why is Clinical Evidence Significant under IVDR?
Clinical evidence essentially demonstrates that an IVD medical device meets its intended purpose and does not compromise the health or safety of patients when used as intended.
Key Components of Clinical Evidence in IVDR
Performance Evaluation Report (PER): A crucial document that compiles all the clinical evidence related to the IVD medical device. The report should include details about the IVD medical device’s scientific validity, analytical performance, and clinical performance.
Scientific Validity: scientific validity refers to the scientific link between a specific biomarker (the analyte that the test measures) and the clinical condition or or physiological state.
Analytical Performance: analytical performance refers to an IVD medical device’s ability to accurately and reliably detect a particular substance or marker in a given sample.
Clinical Performance: clinical performance refers to the ability of an IVD medical device to accurately diagnose or predict the clinical condition or disease in the target population.
Collecting Clinical Data
Manufacturers have multiple avenues to obtain clinical information:
Clinical Studies: These are often considered the benchmark for deriving clinical data, even if they aren’t always required. The design of each study is tailored to the particular IVD medical device being evaluated.
Research Publications: For technologies or tests with an established presence in the field, manufacturers might rely on current scientific publications to gather clinical insights.
Historical Records: Data from the actual use of an IVD medical device that a manufacturer has sold in the past can offer invaluable clinical insights.
If you’re finding the IVDR tough to navigate, don’t worry – QRcompliance is here to help. Visit our website at www.qrcompliance.nl. We also provide a selection of templates in our online shop to assist you in setting up compliant documentation seamlessly. Let QRcompliance guide you through the intricacies of the IVDR.