Webinar: Periodic Safety Update Report (PSUR) & Vigilance under the MDR

What’s this webinar about?

This webinar will provide you with the relevant information you need to know about for the Periodic Safety Update Report, including what information should be presented and how it should be presented. The webinar will also help you to understand what types of events are reportable under the Medical Device Regulations (MDR).

Who should attend the webinar?

This webinar will offer notified body insights for all people involved in working towards an MDR application and will be of particular interest to those individuals who are involved in post market surveillance activities for their organisation.

What will participants gain?

Join BSI's Richard Holborow, Head of Clinical Compliance, to hear about important insights into what you need to know about the Periodic Safety Update Report (PSUR) and vigilance under the Medical Device Regulation.  Richard will also be joined by Simon Lidgate, Clinical Team Manager (Active Implantable), BSI.

Participants will gain a better understanding of the post market requirements as listed under Articles 86 and 87 of the MDR, and will be able to confidently know which information is required for the PSUR and which vigilance events are reportable.

Richard Holborow is the Head of Clinical Compliance at BSI. Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specialising in implantable cardiac devices and electrophysiology.

Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organisation. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.