Class I medical device manufacturers ask the question whether they are required to provide a Periodic Safety Update Report (PSUR) to notified bodies.
PSURs are not requirements for class I medical device manufacturers. Class I medical device manufacturers are required to do the post-market surveillance reports, similarly to the past. Nevertheless, they have to create that report based on the plan, and this report should be addressing the requirements of systematic and entire lifetime coverage of the device, which is a requirement of the medical device regulation.
