On the 4th of November, we conducted the webinar “PSUR under the Medical Device Regulation: Practical Guide”. In this webinar, we offered practical guidance to the latest PSUR requirements under the MDR alongside PMSR requirements.
Question 1: How is the PSUR and PMS report different in content for Class 1 and Class 2?
To outline the differences between PSUR and PMS reports, please, feel free to refer to the table below developed by our expert team:
Question 2: Is there any template available or foreseen for PSUR?
Not yet. However, the Medical Device Coordination Group (MDCG) has endorsed a guidance to assist companies and many other documents are in the preparation stage. The list was updated in October 2021 for those in preparation and it foresees that a Guidance on Periodic Safety Update Report requirements will be released in Q4 2021.
Question 3: When should we submit the first PSUR now that the MDR has come into force?
No official clarification on this point is available at the moment. For MDs certified according to the MDR the Data Lock Point (DLP) for first PSUR should be one or two (class IIa devices) years following the certification date of the device under the MDR.
Question 4: When will guidelines and a template for the PSUR be available?
Guidance on Periodic Safety Update Report requirements will be released in Q4 2021.
Question 5: How does PSUR template look like?
An unofficial template is available at RIS.WORLD (Magazine Réglementaire des Industries de Santé) website. It presents the PSUR main elements as per Article 86 of the MDR and may be useful as a starting point for building the PSUR process.
Question 6: Which are the main differences between PSUR and PMSR?
For the PMSR it is not required an estimation of patients’ exposure and the submission to Notified Bodies is not requested.
Question 7: When do you think EUDAMED will be fully functional?
On 30 October 2019, the Commission published a notice which foresees the launch of EUDAMED for May 2022 which in turn is linked to the date of application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
Question 8: How about the DSUR? Also for MDs is required?
No, it is not a requirement for MDs
Question 9: Is there a specific deadline for the first PSUR for the legacy devices?
Unfortunately, it is not still clear when the first PSUR for legacy devices should be prepared. The most plausible and conservative approach is to plan it 1 or 2 years (depending on the class of risk) starting from entry into force of the MDR – 26th of May 2021.
Question 10: According to MDCG, “old devices” do not need to comply with MDR requirements (except articles 93 to 100 of the MDR). Does this mean that they do not need to submit a PSUR?
Article 120 § 3 states: “However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.” This means that the PSUR preparation is due for legacy devices.