The MDR and IVDR require either a “Post-Market Surveillance Report” or a “Periodic Safety Update Report” from medical device manufacturers. The Periodic Safety Update Report is abbreviated as “PSUR”, the Post-Market Surveillance reports as “PMS report”.
The MDR requires medical device manufacturers to conduct Post-Market Surveillance (PMS) and thus collect PMS data. This article is intended to help clarify the regulatory requirements manufacturers must consider when collecting these PMS data. Notably, it is intended to highlight whether manufacturers need to consult an ethics committee in Europe if the data arise from…
We need your consent before you can continue on our website.If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission.We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience.Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement.You can find more information about the use of your data in our privacy policy.You can revoke or adjust your selection at any time under Settings.
If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission.We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience.Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement.You can find more information about the use of your data in our privacy policy.Here you will find an overview of all cookies used. You can give your consent to whole categories or display further information and select certain cookies.