Learn the basics of MDR and IVDR regulations!
During the training, you will gain insight into how the regulations affect you as an importer or distributor. We combine theoretical foundations on the roles and responsibilities of economic operators with practical exercises where you will apply your new knowledge. You will also have the opportunity to discuss and do exercises, giving you a deeper understanding of how these regulations are applied in practice.
You will also learn about the importer's and distributor's responsibilities regarding e.g. contracts, document control, complaint handling and traceability, as well as the new requirements regarding suppliers, manufacturers, logistics, purchasing, marketing, deliveries and complaints.
CONTENT
- Basics of MDR and IVDR with focus on distributor and importer requirements
- Definition and explanation of the roles of economic operators
- Stakeholder responsibilities around registration, contract management and document control.
- Requirements regarding traceability, complaint handling and reporting obligations of operators.
- Examples of how importers and distributors can meet their responsibilities
- Practical exercise and discussion
TARGET GROUP
The course is aimed at companies and those who are or plan to become importers or distributors of medical devices and/or in vitro diagnostic products. It is also relevant for manufacturers, suppliers and regions that have the role of distributor. For those in quality, logistics, purchasing and marketing, who need to understand the new regulations and their impact on their business.
SKILLS
No specific prior knowledge is required to participate in this basic training.
