#Iso 13485 updates update
Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III. Manufacturers of class IIb and class III devices shall update the PSUR at least annually. the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.the conclusions of the benefit-risk determination.Throughout the lifetime of the device concerned, that PSUR shall set out: Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken.Post-market surveillance, vigilance and market surveillanceĬooperation between member states, medical device coordination group, expert laboratories, expert panels and device registersĬonfidentiality, data protection, funding and penalties
#Iso 13485 updates registration
Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devicesĬlinical evaluation and clinical investigations Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement
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