Tuttlingen – The new MDCG Guideline 2022-4 stipulates that manufacturers with products in risk classes IIa and higher require a Periodic Safety Update Report, PSUR for short, by May 2022. An information event on April 11 will show ways of tackling the task together.
As with other projects before, MedicalMountains GmbH and Prof. Dr. Hans-Peter Zenner (Prof. Dr. HP Zenner GmbH, Tübingen) suggested promising approaches of working together and having the document created to a certain extent uniformly by an external service provider. In this way, personnel, time and financial resources could be saved in companies and more security gained when dealing with PSUR.
A first digital information meeting will take place on Monday, April 11 at 5:00 p.m. Prof. Zenner explains the topic and the possibility of a collaborative approach. After the meeting, the participants can decide whether they want to participate in the project.
Marena Hauser, hauser@medicalmountains.de, accepts registrations for the information meeting and sends the access data to the participants.
