EU MDR

The EU requirements for importing medical devices have been changed from the MDD to the EU MDR. Gain an understanding of what is now required to export to the EU.

The EU MDR replaces the MDD and expands the conformance requirements. It became effective in May 2021. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes". In contrast, the MDD has 60 pages. The size comparison illustrates the increased requirements.

New requirements have been added and existing requirements have been expanded.

• Emphasis is placed on a life cycle approach to regulation and on post-market surveillance and risk assessment
• Greater emphasis on clinical data and evaluation; reliance on “Substantial Equivalence” equivalence to an existing device is discouraged
• UDI requirements are added for the purpose of device traceability
• Accountability for device issues and failures expanded to other parties (Economic Operators in the supply chain)

Products intended to be imported into the EU must conform to these new regulations. Arrangements must be made with a Notified Body, an Authorized Representative, and a Person Responsible for Regulatory Compliance.

It is essential to understand the changes and the impact they will have on your organization. Gain the knowledge you need to lead your company's EU MDR implementation project.

This course will be presented in modules, with many interactive exercises. Click on the "agenda" tab above to view a list of topics covered in the course.>