EU MDR
EU MDR is a regulation on clinical investigation & sale of medical devices for human use. It repeals Directive 93/42/EEC, which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021
What we do?
1. Notification to suppliers regarding the presence of EU MDR substances in the Medical Devices.
2. Assisting suppliers in complying with EU MDR regulations.
3. Collecting EU MDR Declarations/ Certificate of Conformity from global suppliers.
4. Any specific information related to EU MDR based on the customer requirement.
2. Assisting suppliers in complying with EU MDR regulations.
3. Collecting EU MDR Declarations/ Certificate of Conformity from global suppliers.
4. Any specific information related to EU MDR based on the customer requirement.