The participants will achieve an understanding of the new obligations to medical device Economic Operators according to the Regulation (EU) 2017|745 of 5 April 2017 to have effect from 26 May 2022.
The Economic Operators will include medical devices manufactures, authorized representatives, importers and distributers.
The participants will achieve an understanding of the obligations of Economic Operators (EO) with respect to Competent Authorities, Notified Body and the other operators in the supply chain of medical devices. An overview of all activities and documents to be established regarding compliance with the new rules will be presented.
The new Regulation is amending the obligations to all stakeholders in the supply chain of medical devices. These obligations include in addition to the existing requirements of the Medical Devices Directives Post Market Surveillance and vigilance reporting systems for all EO, furthermore, registration with the EUDAMED database for medical devices and establishing of UDI codes including requirements for traceability between the EO’s will be addressed during the course. Finally, all obligations per Economic Operator will be covered and the implications discussed.
Who should attend
This course is targeted at:
- Product design engineers
- Risk managers
- Regulatory managers
- Project managers
- Quality managers
Liselotte Blond Sørensen, Senior Consultant and Partner, DMD Consulting