PSUR frequency
Answer two short questions and see which post-market report your device needs under the EU MDR or IVDR, how often it must be updated, and where it goes.
Book a 30-minute call
Tell me about your device and its certificate, and we will plan the PMS reports and their timing together.
The tool shows the minimum frequency set by the regulation. Your notified body or your own procedure may ask for more, and new safety data can call for an earlier update.
Enter the date of your last PSUR to see when the next one is due at the latest.
Want me to check this with you?
Which regulation applies to the device?
What is the device class?
When did you issue the last report?
This tool is not available yet.
Answer the questions and the report type, how often it is updated and where it goes will appear here.
Your post-market report
A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.