Navigating EU's Medical Devices Regulation 2017/745 (MDR)
The European Medical Devices Regulation 2017/745 (MDR) now applies in the world’s second-largest medical device market. The new Regulation introduces major changes to how medical device manufacturers obtain CE Marking and maintain access to the European market, yet some companies may have yet to come fully into compliance with these new requirements, or organize their regulatory transition strategies.
Key MDR compliance requirements and challenges
An effective roadmap to MDR compliance involves multiple components. MDR requirements, such as conformity assessments and sufficient clinical evidence, are more expansive and complex than those of the MDD, which means manufacturers must now address issues including:
- Total product lifecycle approach to CE Marking certification
- Learn how MDR affects human factors engineering and usability requirements
- Enhanced post-market surveillance and post-market clinical follow-up (PMCF) requirements
- Notified Body capacity: When does your NB plan to obtain MDR designation?
- Changes to European Authorized Representative (AR) roles and agreements
- Eudamed database submission requirements for manufacturers, devices and other economic operators
Download our MDR Readiness Checklist to quickly assess your level of compliance with the new regulation and identify next steps.
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