Webinar | Unlocking MDR’s Holy Grail: How Real-World Data for Medical Devices Can Fast-Track Indications, PMCF and Earlier Access to Innovation

“Unlocking MDR’s Holy Grail: How Real-World Data for Medical Devices Can Fast-Track Indications, PMCF and Earlier Access to Innovation’’

Join BSI and Evnia for an expert-led webinar featuring Breda Kearney, Clinical Regulatory Lead, Medical Devices at BSI.

Organised by Evnia and hosted by Dr. Vicky Valla, Regulatory Compliance Lead.

The session will explore how real-world data can be used under MDR to support CE marking, post-market clinical follow-up (PMCF), post-market surveillance (PMS), and indication expansion. The discussion will address regulatory expectations, notified body perspectives, and practical challenges manufacturers face when leveraging real-world evidence.

📅 Date: Wednesday, 3 June 2025
🕓 Time: 16:00 CET
📍 Format: Online (Microsoft Teams)

Registration is required.
After completing registration, you will receive access to the Teams webinar link. Registered participants will also be able to submit questions in advance.

Register here.
We strongly encourage you to submit any questions prior to attending the webinar. You can submit your questions here.