In the field of medical device manufacturing, risk management plays...
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It is very critical to assess the performance of any In-Vitro Diagnostic device before being commercially sold. The European Union has taken extra measures to ensure that no non-conforming or poorly performing device enters the market by modifying the existing directive with a regulation, i.e. the EU 2017/746 Regulation under which the performance and the post-market activities have become more stringent. The new European IVD Regulation (EU IVDR), specifies the requirements of effectively carrying out this performance evaluation and submit the Performance Evaluation Report (PER).
The ultimate aim of performing this performance evaluation is to analytically and clinically prove that the device supports the manufacturer’s intended use. As per Article 56 of EU IVDR, the performance evaluation of any IVD device shall be determined based on the following:
Within the Performance Evaluation Report (PER), the manufacturer must demonstrate satisfactory clinical evidence that supports the intended use for the device in healthcare sector and this needs to be rationalised throughout the life cycle of the device for supporting clinical evaluation of medical device. For successful IVDR compliance, manufacturers of IVD medical devices are required to be vigilant all through the performance evaluation process, that includes planning, collecting and assessing the clinical evidence data and preparing and submitting the Performance Evaluation Report (PER), as part of the IVDR technical documentation for NB assessment.
Maven performs a systematic review of the scientific literature, checks the adequacy of existing testing performed and develops performance evaluation plan along with a compliant Performance Evaluation Report (PER).
For further information refer the following MDCG endorsed documents:
https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_1_guidance_clinic_eva_md_software_en_0.pdf
https://health.ec.europa.eu/system/files/2023-01/mdcg_2022-19_en.pdf
https://health.ec.europa.eu/system/files/2022-12/mdcg_2022-20_en.pdf
