The Medical Device Regulation (MDR) is the new regulation that replaces the Medical Device Directive (MDD).
Click on the image below to see LRQA's infographic of MDR key changes and key dates timeline.
- Wider scope of regulated medical devices
- More stringent clinical evidence and documentation
- Increased focus on identification and traceability
- Definition of common specifications
- Unannounced factory audits
- Increased Notified Body authority and/or involvement
- More rigorous vigilance and market surveillance
- At least one person responsible for regulatory compliance