The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices worldwide. It was first implemented by the American Food and Drug Administration and has since been adopted by the European Medical Device Regulation (MDR) and several other country specific regulations.
UDI requires manufacturers and labelers of medical devices to:
· Include Unique Device Identifiers (UDI) on device labels and as direct marking on the device itself (for specific devices)
· Submit device information to the Global Unique Device Identification Database (GUDID) and EUDAMED
Swiss MPC offers simple, low-cost solutions regardless of whether you are introducing a new medical device or looking for assistance in assuring compliance for existing devices in your product portfolio. Our FDA consultants can assist with UDI compliance.
How Swiss MPC supports your UDI Compliance efforts:
· Identifying appropriate accredited UDI issuing agencies (e.g. GS1)
· Product, labeling, and gap assessments for UDI compliance
· UDI training
· UDI project management
· Assisting you to incorporate UDI processes into your quality management system and production operations
· Direct product marking and UDI barcode verification consulting
· Ensuring proper UDI data formatting for submitting to GUDID and EUDAMED
· Guidance on supply chain management and validation
Benefits of using Swiss MPC
- Efficient Expertise - Our team has a wide range of exposure and experience accross the medical device landscape
- Competitive fees
- All in one team based solution
- Excellent availability and fast project on-boarding
- Senior Consultants as single point of contact
- Staffing from 0.5 to 10 FTEs within 3 weeks
- Fully remote working options available
- Full quality control by Senior Consultants in Switzerland