With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.
How simple labeling changes can drive big results for medical device manufacturers.
FDA requires that manufactures establish and maintain procedures regarding labeling activities.
The United States paves the way for seamless compliance.
The agency clarifies the UDI rule for labelers and accredited issuing agencies.
Are you UDI-ready? Get the facts to achieve compliance fast.
The unique device identification rule is far more than just a labeling rule.