Periodic Safety Update Reports:  Why You Might Need One

Periodic Safety Update Reports

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 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!

Our Literature Review

Please provide your email and we will send you  our documentation on MDR Literature Reviews