Learn about the key requirements, concepts, and the overall process for CE marking under the Medical Devices Regulation (MDR). The CE mark gives access to a market with 500+ million people.
The course will give you an understanding of the key requirements, which will provide:
- Essential knowledge to understand Regulatory Affairs of medical devices in EU, e.g. in the position of top management, or a manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
- The ability to understand the demands of the subcontractor, supplier, OEM, authorized representative, importer, distributor, allowing better relationships between them and the legal manufacturer
- A basis to learn later about implementation of CE marking projects
How will I benefit?
This course will help you:
- Understand the key requirements and concepts of the European Medical Devices Regulation
- Communicate the impact of the key requirements introduced by the MDR to your organization
- New starters in Regulatory Affairs (RA), personnel increasing their responsibility in this area, and RA professionals who are not familiar with the European MDR
- Personnel working with Regulatory Affairs departments, e.g. top management, manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
- Staff working for organizations that partner with Medical Device manufacturers, e.g. as subcontractor, supplier, OEM, authorized representative, importer, distributor, auditee etc.
We also offer an equivalent training course for the requirements of the In Vitro Diagnostic Regulation.
By the end of the course delegates will be able to:
- Communicate the key requirements and concepts within the Regulation
- Reference the necessary aspects to evaluate if and how your company is affected by MDR and to what extent
- Define the vocabulary used within MDR
- Explain the structure and administration of the Regulation
- Recognize partners of manufacturers affected by the Regulation
- Describe key steps of a conformity assessment
- Explain the main impacts on the QMS relating to MDR
- Recognize requirements for post-market surveillance and updates
- Training course notes
On completion, you'll be awarded an internationally recognized BSI Training Academy certificate
We are now offering this training as online training course as well.