In the previous article, we gave a first insight into the various possibilities of what is hidden behind the abbreviations MDR and PSUR. After this short excursion to India, we would like to turn our attention to the European PSUR in detail, because here, too, there are enough abbreviations to cause confusion.
First, let’s clarify the question of origin:
The PSUR “Periodic safety update report” or “Periodic safety update report” is required by Article 86 of the MDR. It is based on the corresponding previously established PMS plan – “Post-market surveillance plan” according to Article 84.
The aim of the PSUR
The PSUR is intended to make as much data as possible, which has also previously been collected under the MDD and the current EN ISO 13485 (would have), available in a coherent report as part of the technical documentation.
That sounds dry? Well, it is detailed work that requires the responsible persons to clearly distinguish between the different data sources.
These sources may include:
Research on relevant notification portals on notifications of similar products (BfARM, MAUDE, Health Canada, swissmedic, etc.),
Reports and evaluations of notifications by users and third parties that are processed in the complaints system. Ultimately, all reports are relevant here, regardless of whether they have led to a reportable event or only reveal a general trend regarding the product.
Information on misuse (off-label use) as well as other information submitted by users, distributors and importers
Literature or registries identified, for example, as part of the clinical evaluation.
The expectation is that the PSUR will reconcile the data obtained with the current benefit-risk assessment, i.e., that this may need to be adjusted, and that the main results obtained will be reported. And to put it all in perspective, the total sales volume must be mentioned, as well as an estimate of the number of people using the product and their characteristics mentioned use.
The PSUR is part of the PMS
As part of the PMS, the PSUR is populated with data from the RM, CER, PMCF, and QA, among others, and mapped into the TD.
Described in more detail, this means that a meaningful Post Market Safety Update Report will summarize the results of post-market surveillance activities, it will pick up information from Risk Management and the Clinical Evaluation Report, it will plan and evaluate additional post-market clinical follow-up activities, and it will rely on process data collected by Quality Assurance.
All of these are already activities that you typically perform. What is new is that you must perform them all in a documented and systematic manner, and transfer your obtained process data to the Technical Documentation.
We are happy to offer you help in complying with and merging all this data to be systematically recorded, so that you can concentrate on the essentials in the face of all the detailed work.
Please note that all data and listings do not claim to be complete, are without guarantee and are for information purposes only.
