Periodic Safety Update Report

The Periodic Safety Update Report  is one of two new post-market reports that medical device manufacturers must keep and submit to their Notified Body (NB) regularly. This data supports competent authorities and Notified Body in determining the risk-benefit ratio of the device in compliance with EU 2017/745 CE Marking. The information acquired through these reports helps both patients and healthcare providers stay up to date. The Periodic Safety Update Report is intended to improve medical devices and their advantages to patients.

A Post Market Surveillance Report is required for all devices. The device class’s risk level specifies the type of report, and whether it must be evaluated by a notified body. Low-risk device manufacturers are not required to submit a PSUR, but they must keep a PMSR and make it available to responsible authorities. The Post Market Surveillance Report must include evidence and a description of any corrective actions taken, as well as a summary of the outcomes and conclusions of post-market surveillance (PMS) data.

According to EU MDR article 86, the Periodic Safety Update Report must be provided by manufacturers of medium and high-risk devices (class IIa, IIb, and III) and it must be prepared for the device’s entire lifetime once it has been released to the market. PSURs for high-risk devices must be updated on an annual basis. This is applicable even if the certification is valid for two years. PSURs for Class III devices must also be submitted to Notified Bodies electronically such as EUDAMED. For all other classes, the PSUR must be made available to Notified Bodies and, upon request, to competent authorities.

According to MDR, PSURs must include the following:

 A]   Post Market Surveillance Data

Post market surveillance is a set of activities carried out by manufacturers to collect and evaluate experience gained from medical devices placed on the market and determine the need for any action.

B]   A comprehensive benefit-risk analysis and conclusions of risk-benefit determination 

Benefit-Risk Analysis is critical in the approval of medical devices; thus, manufacturers must have a team of professionals and consultants to evaluate the benefits vs the risks of a medical device. During the design and development phase, benefit-risk analysis allows us to determine the severity of the harms associated with a medical device. Based on that, the manufacturer can change the design and materials or provide more safety controls during use. Medical devices are designed for certain medical purposes, which indicates they provide certain benefits. So, to establish the acceptability of risks associated with a specific medical device, we must consider the benefits against the risks.

C]   Vigilance report

The term “vigilance report” refers to the incident report for death, injury, and malfunction that could result in death or serious injury that is required under the post-market surveillance system. 

D]   The device’s current market status in the EU 

It is important to know the market status of the medical device which was placed in the market to meet the quality and safety requirements for the intended purpose, meaning that the product can be freely marketed anywhere in the Economic European Area and covered as possible as user’s population to assure the safety of the device.

E]   Post-market clinical follow-up 

Post-market clinical follow-up is an active collection of data on clinical experience with the device after the market release, data includes the data that we received from the healthcare centers after monitoring a person’s health over time during the use of the medical device after placing the device on the market. 

F]   Device sales volume and user population estimation and device usage frequency 

The main findings of the PMCF and the volume of sales of the device must all be included in the periodic safety update report, as well as an estimate evaluation of the size and other characteristics of the population using the device, and, where possible, the device’s usage frequency.

The main responsibilities of I3CGLOBAL team are the following

• Assess if more research on a specific issue is required, or if action is required to safeguard public health
• Thorough and critical review of the product’s risk-benefit balance, taking into account new or forthcoming safety information in the context of existing risk benefit data.
• A PSUR assessment can determine if further investigations on a specific issue are needed
• We coordinate entire clinical evaluation and approval, provide Comprehensive Bridging Reports, summaries and analyze published research, and make recommendations for business feedback.

The importance of Periodic Safety Update Reports (PSURs) in monitoring the safety profile of medicinal products cannot be overstated. PSURs serve as comprehensive and systematic evaluations of a medicinal product’s safety data collected during its post-marketing phase. These reports provide a thorough assessment of adverse events, side effects, and any emerging safety concerns, enabling regulatory authorities and pharmaceutical companies to continuously evaluate the benefit-risk balance of the product.

By collecting and analyzing real-world data from diverse patient populations, PSURs offer valuable insights into the long-term safety and tolerability of medicinal products. Through ongoing monitoring, PSURs can detect and identify rare or delayed adverse reactions that may not have been evident during clinical trials. This proactively identifies potential safety signals, allowing for timely risk management and safety measures to protect patients’ well-being.

PSURs also play a crucial role in tracking the effectiveness of risk minimization strategies and safety interventions implemented after a product’s approval, helping to ensure that the product’s benefits continue to outweigh its risks throughout its lifecycle. Overall, PSURs facilitate evidence-based decision-making and contribute significantly to public health by upholding the highest safety standards in pharmaceutical products.

Although this is a thorough list of needed elements, it does not convey the level of analysis required in a PSUR. It is not enough to just include these parts; the data presented in them must be related to the story you present. For example, to determine how frequently complaints, occur, sales volume is connected to product usage. Without this relationship, sales or complaint data is meaningless on its own.

The periodic safety update report thus assists manufacturers in demonstrating to the notified body that their post-market surveillance program makes use of market data to ensure the continued safety and performance of their device.