Regulation (EU) 2017/745 and PSUR (periodic safety update report)

[tb3625]

The new medical device regulation calls for a Periodic safety update report for medical devices class IIa and above.

My question is how the PSUR differs from the clinical evaluation report?

 

[Ronen E]

The PSUR is required to include the following:

1. The device’s sales (unit?) volume.
2. An estimate of the size and other characteristics of the device user-population.
3. Where practicable, an estimate of the usage frequency of the device.
4. A summary of the results and conclusions derived from data gathered under the PMS plan, including the main findings of the PMCF (which is “a continuous process that updates the clinical evaluation”; see Annex XIV part B).
5. A rationale and description of any preventive and corrective actions taken (as a consequence of item 4 above).
6. The conclusions of the benefit-risk determination (see definition #24 in Article 2 and GSPR #8 in Annex I).

 

[tb3625]

 

[dgrainger]

They are different things, you need to look in chapters VI and VII.

PSUR
Article 86
"1 ...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. Throughout the lifetime of the device concerned,"...

clinical evaluation report
Article 61
"12 The clinical evaluation, its results and the clinical evidence derived from it shall be documented in a clinical evaluation report as referred to in Section 4 of Annex XIV, which, except for custom-made devices, shall be part of the technical documentation referred to in Annex II relating to the device concerned."

 

[locutus]

Also keep in mind that your Clinical Evaluation Report (or generally clinical evidence) would be an input to your Post Market Surveillance. While the PSUR has descriptive information about what this will contain (which may change as implementation starts) your clinical evaluation is a component that needs to be reviewed, as well as risk, hazards, vigilance, etc. etc - PMS !

 

[mikinnear]

Following. Thanks.

 

[Sulamistan]

Here's some guidance from BSI about PSUR and CER,

Will the Periodic Safety Update Report (PSUR) need
to be included in the Clinical Evaluation Report
(CER)?

The MDR requires that the Clinical Evaluation is updated
periodically based on Post Market Surveillance (PMS) data.
However, inclusion of the PSUR in the CER is optional. The
PMS data which the PSUR is based on should be used to
update the CER.

bsigroup.com/meddev/LocalFiles/ja-jp/Documents/BSI-MD-MDR-FAQ-JA-EN.pdf

 

[RobertvanBoxtel]

During a recent webinar I heard a NB say that PSUR is not the same as a PMS report and shall not replace the expectations of a PMS report.

As in the EU_MDR there is a differentation clearly between PMS report and PSUR, I tried to obtain clarity, but did not receive a response (sofar).

 

[Marcelo]

The PSUR, CER and PMS report all share similar information, but their purposes and contents are different.

For example, the PSUR is more like a "fact-sheet" updated from time to time that is to be read by users and patients. For more on the PSUR, see these links (PSUR is very common in Pharma)

European Medicines Agency - Pharmacovigilance - Periodic safety update reports

European Medicines Agency - Post-authorisation procedural Q&A - Periodic safety update reports: questions and answers

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500142468.pdf

The CER is the clinical evaluation of the whole device design, and should follow a defined criteria and content (generally identification of applicable ERs, CE Plan, data identification, data appreciation, data analysis, and creation of CER).

The PMS report details data points to be gathered during PMS, questions to be answered, methods used to collect data, methods used to analyze data, things like sampling criteria, and outputs, such as indications of required actions based on findings.

 

[Wolf.K]

Not to forget the SSCP, the Summary of Safety and Clinical Performance...

Gosh, I think we are all going to become writers, not medical device manufacturers...