The Periodic Safety Update Report (PSUR template) is one of the new requirements related to the European Medical Device Regulation EU MDR 2017/745. It is a well known document for the pharmaceutical sector, but rather new requirement for medical devices.
The new MDR has quite a lot of new requirements related to post-market surveillance and the interconnections between clinical evaluation, PMS and risk management play a fundamental role to demonstrate compliance to the regulation.
The content of the PSUR template has been extensively described in the related article of QualityMedDev website, but it can be easily summarised in the following points:
- Benefit risk analysis
- the findings of the post-market clinical follow-up
- Sales Volume and population of use of the device
The way in which this information is presented is critical and, at the same time, there are multiple possibilities on the modalities to fulfil these requirements and the data that are used to demonstrate the safety of the device on the market.
Here at QualityMedDev, we present a Periodic Safety Update Report Template that could be used as starting point for the construction of your PSUR report. The template is a 6 pages long document containing clear suggestions and indications on how to prepare the Period Safety Update Report for your medical device.
This Periodic Safety Update Report Template is fully editable in word, can be used as starting point for the construction of your risk management process and it is fully compliant with the EU MDR 2017/745.
Do not hesitate to download the product!
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