MDR Article 86 Periodic safety update report reads:
1.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. ...
Two questions:
1. PSUR is a well known requirement in the pharma world (see attached template from EMA (virus scan before use )). Is it now required for all medical devices in class IIa or higher even if they do not administer medicinal products?
2. Does anyone already have a decent PSUR template and is willing to share it?
Many thanks to the loyal readers (and am I glad that Elsmar is back)
1.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. ...
Two questions:
1. PSUR is a well known requirement in the pharma world (see attached template from EMA (virus scan before use )). Is it now required for all medical devices in class IIa or higher even if they do not administer medicinal products?
2. Does anyone already have a decent PSUR template and is willing to share it?
Many thanks to the loyal readers (and am I glad that Elsmar is back)