As part of an ever-increasing improvement in post-marketing surveillance activities for medical devices, the new EU regulation 2017/745 introduces the obligation for the manufacturers of class IIa, IIb and III to prepare a periodic safety update report (‘PSUR’) for each device (and where relevant for each category or group of devices) reporting the results and conclusions of the analyses of the post-market surveillance data together with the description of any preventive and corrective actions relevant to safety.
Manufacturers of class IIb and class III devices will have to update the PSUR at least annually and, except in the case of custom-made products, the document is part of the technical documentation as specified in Annexes II and III. Otherwise, manufacturers of class IIa devices will update the PSUR when necessary and at least every two years.
Lastly, for custom-made devices, the PSUR will be part of the documentation referred to in Section 2 of Annex XIII.
The PSUR will report:
- Information on feedbacks from the market and incidents reported in the concerned period
- the conclusions of the benefit-risk determination
- the main findings of the PMCF (if any)
- the volume of sales of the device and an estimate evaluation of the size and other features of the population using the product (and, where practicable, the relevant usage frequency)
A common PSUR template to be used in all EU countries is currently under revision at central level and it will be available in the next months.
In case of class III devices or implantable ones, manufacturers will have to submit PSURs in the EUDAMED database (once it will be available); the notified body involved in the conformity assessment will access to the document through EUDAMED. The notified body will review the report and add its evaluation in EUDAMED specifying the details of any action taken. It remains to be defined the timing requested by the Notified Body to evaluate the PSUR. It should also be noted that the PSURs and the evaluation by the notified body will be made available to competent authorities through EUDAMED, upon request.
Regulatory Pharma Net is available to support companies for the identification of a proper post-marketing surveillance strategy and PSUR preparation, as well as, to provide additional information and advice on quality and regulatory aspects to be compliant with the new Regulation 2017/745.