Manufacturers of class IIb and class III devices shall update the PSUR at least annually. Size and other characteristics of the population using the device and, where practicable, the usage frequency of the device. The volume of sales of the device and an estimate evaluation of the The conclusions of the benefit-risk determination Throughout the lifetime of the device concerned, that PSUR shall set out: (a) 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.
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