European Medical Device Regulations (EU MDR) - Webinar Recording/Transcript
European Medical Device Regulations (EU MDR): Strategic Planning for the Coming Critical Changes
Devicemakers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations.
In 175 pages of eye straining text, you’ll encounter unfamiliar rules and terms… expanded General Safety and Performance Requirements… increased requirements for risk management and post-market surveillance… and much more.
You have until May 2020 to comply.
James Pink, a device expert with extensive EU experience, brings his expertise to you.
- The new MDR classification system: How to apply the system
- New separate software rules and what they say
- Stricter requirements for implantable devices: The impact on quality and compliance
- The consequences of delay: Sanctions you could face, markets you could lose
The new EU-MDR is a handful. It will change how you do business everywhere in the world.