The European Union’s Medical Device Regulation commonly referred to as “MDR”, came into effect from May 26, 2021. It is intended to improve the quality of medical devices and promote a lifecycle approach for medical device regulation. Broadly, it is focused on enhanced quality and compliance with specific focus on the following:
- The pre-approval stage of medical device manufacturing
- Standardizing manufacturing practices
- Ensuring compliance through data visibility, transparency and sustainability of quality metrics across the product lifecycle
This whitepaper kit is divided into the following broad topics:
- MDR – a quick overview
- Implications of MDR for device manufacturers
- EUDAMED with its 6 interconnected modules
- Role of QMS in ensuring compliance
This compliance kit also comes with directions to further checklists, whitepapers and webinars that will help you get a thorough perspective of what it takes to meet the EU MDR regulations.
