Demystifying EU CTR, MDR and IVDR
Submission strategies for clinical trials involving medical devices and in vitro diagnostic devices
Technology is transforming medical interventions.
Sponsors are developing innovative new treatments that deploy medical devices, combination products and diagnostic medical devices. But for every new development there are many regulatory hurdles to overcome.
In the EU, sponsors must comply with three major regulatory requirements: Clinical Trials Regulation (CTR), Medical Devices Regulation (MDR) and In Vitro Medical Devices Regulation (IVDR). Additionally, sponsors may face separate national regulation, ethical and safety requirements.
Download the whitepaper to learn more about:
- CTIS and EUDAMED electronic portals
- Conformity assessment of medical devices and in-vitro diagnostic devices
- Clinical performance and clinical evaluation under MDR and IVDR
- EU MDR and IVDR submission requirements and timelines
- Submission strategies for combination studies
Whitepaper
Download now and demystify the EU regulation process for medical devices, in vitro diagnostic devices and combined studies.