An introduction to MDR & IVDR especially for those who have the role of importers or distributors
The medical devices and in vitro diagnostics industry is subject to the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). This course provides you with insight and knowledge on, among other things, definitions and the requirements imposed on economic operators, such as verification and market surveillance.
After the training, you should have an increased knowledge of the importer's and distributor's responsibilities regarding e.g. contracts, document control, complaint handling and traceability.
From the contents:
- Basic information on the new regulatory framework, focusing on the requirements for economic operators - distributors and importers
- Definition and explanation of the roles of economic operators
- Responsibilities of the importer and distributor (contracts, document control, complaint handling and traceability)
- Practical exercise and discussion
Lecturer is Maria Prans Liljevret, consultant at Plantvision
Times: 09:00 - 15:00 (including break for lunch)
Location:Hybrid: you participate via link or in the hall on Sveavägen. Please note this in your registration.