C2: Post market surveillance and periodic safety update report (PSUR)

15:15-15:35 Volker Sudmann: Looking beyond the horizon – what matters regarding PSUR

The European Medical Devices Regulation requires extensive documentation of all post-market activities in the form of a periodically safety update report (PSUR). To prevent this from becoming a documentation nightmare and a red tape burden, we take a closer look at PSUR and see what really matters.

15:40-16:00 Viktoria Knoflach: Post-Market Surveillance requirements and submission of PSURs for class III / Implantable devices

For maintaining a product certification for class III / Implantable devices the manufacturer must keep up to date technical documentation, which includes amongst others Periodic Safety Update Reports (PSURs). The PSUR must be updated yearly and undergoes scrutiny by the notified body. As an early adopter of the MDR, receiving MDR certification in March 2020, MED-EL submitted the first PSURs before any MDCG guidelines were available. As such the updating of the PSUR as well as the reviewing process by the notified body has seen significant changes over the past 4 years. 

16:05-16:25 Birgit Sebauer: PMS and its requirements in countries beyond Europe

Fulfilling requirements and keeping up to date within the EU is already challenging, considering the situation that medical devices are also sold outside EU (e.g. Switzerland, UK, US, Asia) the complexity of fulfilling requirements increases. As an international company selling class I, Is and IIa products worldwide the developments in the different countries have not made our life easier. We will look into similarities and differences between EU requirements and requirements from other countries not to forget how to deal with private labels and respective customer needs.