Are you prepared for the EU Medical Device Regulations?
The EU MDR brings significant new compliance requirements across the full medical device lifecycle. The following are key highlights:
- New guidelines for clinical evidence and safety requirements
- Increased transparency and traceability, requiring the use of Unique
Device Identification (UDI) across the device lifecycle and registration of Economic Operators
- Increased designation requirements for Notified Bodies, as well as stronger mandates related to medical device assessment and safety standard consistency
- Premarket data requirements for high-risk devices, including definition and application of common specifications
- Mandatory, continuous, and time-bound updates on device information, registration, clinical investigations, and vigilance to be supplied to the European databases for medical devices (Eudamed)
- Increased governance oversight to ensure consistency of standards enforcement.