UDI Consulting

Unique Device Identification (UDI) requirements for medical devices are currently being implemented by Health Authorities like FDA, EU (under new MDR) and MHRA making Unique Device Identifier (UDI) mark mandatory on labels and packages of most medical devicesand other global health authorities are expected to adopt similar programs in the coming years. To be UDI compliant, regulatory data management and on-time submission is necessary.

In order to establish compliance you need to follow the following steps:

1. Get your DUNS number that will help in identifying your labeller
2. Appoint someone who would work as a contact between you and the authority.
3. You need to have separate UDIs for each of your product.
4. Know your Global Medical Device Nomenclature (GMDN) code or CND (for EU)
5. Submission of Device Information.

These processes are essential to successfully receive your UDI and Makrocare would be there with you right from the beginning till the end.

Our Role

Your regulatory team can manage all the compliance related aspects with our regular assistance. In addition, we provide some other services like:

• Gap assessments for UDI compliance
• UDI readiness assessment
• Complete data analysis and management (collection, collation, validation and implementation).
• Helps you implement UDI processes compliant with latest regulations into your quality management system and operations
• Develop road map identifying right accredited UDI agencies
• Compliance assurance for both new or existing products placed
• Provide support on supply chain process and validation to support UDI implementation

Why MakroCare?

Our expert team has combineddecades of experience in UDI to offer training and assist your teams. Whether you are beginner or bringing a new product to the market, entering new market or reinforcing compliance on current products in your portfolio, we help you build a plan that ensures timelines are met by speeding up the process, and your resources are not exhausted.

• You get UDI regulations from all the health authorities at one place.
• Support for current and future submissions with end to end life-cycle maintenance
• Apt analysis and suggestion based on your established process.