MDR 2017/745: Where Compliance Becomes Trust in Substance-Based Medical Devices
Day 2 Global Pharma Outlook Stage
07/10/2026 14:15 - 14:40pm
Contributors
Agnieszka Dzienynska : Director of the Research and Development, Regulatory Affairs and Quality Department - Gofarm Medical Devices
Every medical device carries a promise: that it works and protects patients. This speech shows why that promise now has teeth.It shows how the MDR (2017/745) gave that promise real force after failures in Europe’s former system. We explain stricter classification, UDI traceability, EUDAMED and continuous post-market surveillance, with particular focus on substance-based devices such as gels and sprays.
We also examine the risks of relying on legacy MDD-certified devices as 2027–2028 deadlines approach, and why switching early supports continuity of care. MDR compliance becomes trust, safety and competitive advantage.
The session will also present Gofarm’s expertise in substance-based medical devices. With one of the largest MDR-certified product portfolios in the EU, Gofarm demonstrates how regulatory compliance can become a foundation for patient safety, continuity of care, market credibility and competitive advantage- on examples.