Your Comprehensive EU MDR Compliance Kit

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.