Are you dealing with the Medical Devices Directive? Medical device manufacturers like you are addressing multiple issues to comply with EU MDR and IVDR regulations. Understanding of the requirements (which vary according to the treated products and the Countries) can be challenging; implementation aspects and Data and information management with EUDAMED are other open key points. What are the technical implications to be evaluated?
This whitepaper addresses these topics:
- UDI code definition, classification, coding deadlines
- UDI Carrier: where to apply it? Challenges and technologies for a correct marking
- Connection to EUDAMED. Methods, technical aspects, and deadlines
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