ECONOMIC OPERATORS’ OBLIGATIONS TRAINING – upon request

The Medical Device Regulation (MDR) specifies categories of economic operators that have specific obligations defined per Article 2 which include manufacturers, authorized representatives, importers, distributors and operators which sterilize or assemble procedure packs or systems under Article 22(1) and 22(3) (MDR requirement).
In this training session, you will gain a detailed understanding of the obligations in the context of the MDR and IVDR under Articles 10 to 14 for economic operators and of the importance of engaging competent organizations in your supply chain. The training will allow you the opportunity to engage with the trainer and discuss topics which regard the economic operators’ responsibilities as well as gain training evidence to demonstrate competence in your role as an economic operator.

• Opening remarks
• Introduction to EU MDR
• Roles of each economic operator under the EU MDR
• Requirements and considerations for economic operators
• Q&A session
• Closing remarks

• Start 02:00 PM – End 06:00 PM. Attendees are recommended to login 15 min in advance.

In order to keep the training interactive, the exact content schedule cannot be provided.