Periodic Safety Update Reports: Why You Might Need One Annually

Periodic Safety Update Reports: Why You Might Need One

Did you know that the Literature Searches you submit for your CE Marking Clinical Evaluation Report might have to be re-run annually?

Most that have already submitted an MDR compliant CE Marking Dossier for their products are aware of the need for Literature Searches/Reviews within a Clinical Evaluation Report.

Article 86 of Reg 2017/745 also outlines the need for a “Periodic Safety Update Report” which is not filed with your initial submission, but instead filed each year thereafter (or on less frequent basis).

Required Frequencies

If your device is classified as IIb, or III this report must be updated annually.

For class Ila devices the requirement is at least every two years.

Class I devices are not mentioned explicitly, but you can be sure that some form of compliance will need to be shown in your Post Market Surveillance and Vigilance plan (every 5 years for example).

Requirements

There are three broad requirements outlined in the Article:

The conclusion of the benefit-risk determination

The manufacturer must outline their updated conclusion on the current benefit-risk of the device. This conclusion should take into account the most recent Clinical data and Scientific Literature researched by the manufacturer as part of this report.

Main findings of your Post Market Clinical Follow-up

This section should cover the details of what was find within the research. A Literature Search would be an effective form of conveying findings along with appropriate medical analysis of that data.

Volume of sales and estimated size of population using device.

The Regulation language here indicates that the Notified Bodies are interested in monitoring the type of person using the device as well as the amount of them. This section should report estimated numbers of population growth since the previous reporting.

The Best Way to Satisfy the PSUR

We believe that a comprehensive Literature Review on an annual basis will best meet the requirements of point #1. For our clients, we simultaneously re-run their previously defined search terms across multiple Scientific Journals and Databases while also collecting all adverse events filed in databases across the world.

By reviewing all of the latest research, publications and adverse events reported, you can clearly show the relevant Notified Bodies that your firm is abreast of the absolute latest developments related to your product.

We manage this research internal with our Review Management System that automatically compiles the relevant pieces of research/events for our Regulatory staff to review, however the process could also be done manually by a diligent enough compliance officer on an annual basis.

If you’d like to hear how the team at CiteMed can save your regulatory team time in conducting on-going Literature Searches and Reviews please contact us today!

Periodic Safety Update Reports: Why You Might Need One Annually