Spotlight

EU Medical Device PMS Report and PSUR

Manufacturers are required to summarise the results and conclusions of the post-market activities which have been conducted in accordance with a PMS Plan and record a rationale and description of any further corrective or preventive actions which may need to be taken. This shall be done for each device, category or group of devices for a given reporting interval. For Class I medical devices and Class A and B IVDs, the report takes the form of a Post-Market Surveillance Report. Manufacturers of higher risk devices including Class IIa, IIb, III medical devices and Class C, D IVDs are required to put together a Periodic Safety Update Report (PSUR).

Summary

PMS Report & PSUR Content Overview

 PMS ReportPSUR
ClassificationsMDR: Class I
IVDR: Class A, B
MDR: Class IIa, IIb, III
IVDR: Class C, D
Content
Summary of Results of PMS ActivitiesXX
Conclusions of Analyses of PMS ActivitiesXX
Rationale & Description of Corrective or Preventive Actions to be takenXX
Conclusions of Benefit-Risk Determination X
Main findings of PMCF X
Sales Volume X
Estimate of Size & Other Population Characteristics X
Estimate of Usage Frequency, where applicable X
Summary of the requirements of the PMS Report and PSUR in the EU MDR and IVDR.

PMS Report & PSUR Update Frequency

 When NecessaryEvery 2 years (at least)Annually (at least)
MDR: Class I
IVDR: Class A, B
X  
MDR: Class IIaXX 
MDR: Class IIb, III
IVDR: Class C, D
X X
Summary of how often the PMS Report and PSUR are required to be updated.

Report Availability

 Competent Authority (when requested)Notified BodyEudamed
MDR: Class I
IVDR: Class A
X  
MDR: Class IIa
IVDR: Class B, C
XX 
MDR: Class III
MDR: Implantable
IVDR: Class D
XXX
Summary of to whom the reports shall be made available.

Post-Market Surveillance Report

The PMS Report is described briefly, with very few specifics, in Article 85 and Article 80 of the EU MDR and IVDR, respectively. Data resulting from post-market activities shall be collected and assessed within the report. The PMS Report shall be provided to the Competent Authority, upon request and should therefore be updated at regular intervals.

Periodic Safety Update Report

On the other hand, the expected content of the PSUR is described in Article 85 and Article 81 of the EU MDR and IVDR, respectively. The overall concept remains the same: summarise the results of post-market activities and justify any further actions being taken.

The manufacturer is expected to provide a PSUR for each device, and where relevant for each category or group of devices. Throughout the product’s lifetime, the PSUR shall set out:

(a) the conclusions of the benefit-risk determination;Has the data collected affected the overall benefit-risk?
– New information gathered in the post-market phase as more patients or users use the device.
– A rare adverse event may not have been identified during clinical trials.
– New data from PMCF demonstrating benefits to new indications or measuring risks.
(b) the main findings of the PMCF; andDiscuss the main findings of the PMCF study conducted.
(c) the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.– Provide the sales data for the given investigation period.
– Estimate the population using the device (size, demographic, other). This can be tricky for reusable devices and should be calculated taking into account how often the device may be used on average.
– Estimate the usage frequency of the reusable device.

The PSUR will need to be provided to the Notified Body as part of their conformity assessment procedure. Manufacturers of Class III and implantable medical devices, as well as Class D IVDs will be required to upload the latest PSUR to Eudamed, when this function becomes available. Following review and acceptance, the Notified Body will electronically confirm the PSUR within the Eudamed system.

How should the PMS Report or PSUR be updated?

The PMS Report and PSUR are intended to be single, stand-alone documents for a particular reporting interval, based on cumulative data. This means that for every reporting interval, the manufacturer shall take into account the data collected for that particular period, however, this shall be added to the pool of data already collected. The benefit-risk needs to be determined based on all acquired data, present and past.

Structure of the PMS Report and PSUR

With an absence of formal guidance on the structure of the reports, we recommend the following:

SectionPMS ReportPSUR
Reporting IntervalXX
Introduction & ScopeXX
ObjectivesXX
Device DescriptionXX
Implementation of PMS PlanXX
Summary of Activities Conducted, their Results, and ConclusionsXX
PMCF Findings X
Sales Volume X
Use Evaluation X
Benefit-Risk Determination X
Corrective or Preventive ActionsXX
Technical Documentation AmendmentsXX

How can Specculo help?

The PMS Report and PSUR are critical elements of compliance with the EU MDR 2017/745 and IVDR 2017/746. Putting these documents together can be difficult, time-consuming, and frustrating.

We have the expertise and resources to prepare either of these documents for your products. Furthermore, we can put together a robust PMS system in order to comply with your obligations and EU regulatory requirements.

See our Regulatory Consulting page for more information on other services we provide.

Contact us today for a free initial consultation.