EU MDR Compliance: A Complete Guide
Understanding and Complying with the EU Medical Device Regulation
The European Union (EU) Medical Device Regulation (MDR) (2017/745) is a regulatory framework that governs the production and distribution of medical devices in the EU. It holds medical device manufacturers to strict safety standards regarding the use of harmful substances in their devices. The regulation replaced the EU Medical Devices Directive (MDD) (93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD) (90/385/EEC).
Enacted in May 2021, the MDR is still in its implementation phase with various deadlines for distinct types of devices. It's critical for manufacturers and distributors of medical devices to understand the regulation, how their devices are classified, and how to achieve compliance before the MDD and AIMDD are phased out and the MDR is fully enforced.
In this e-book, we will explore:
- Understanding the European Union Medical Device Regulation
- What is the EU Medical Device Regulation?
- Which substances are restricted by the EU MDR?
- What are the implementation timelines for the EU MDR?
- What is the difference between the EU MDR and IVDR?
- Classification of Medical Devices Under EU MDR
- Device Classes
- Device Categories
- How to classify a medical device
- Achieving EU MDR Product Compliance
- Medical Device
- Clinical Evidence Portfolio
- Regulatory Systems, Processes, and Documentation
- Assessing compliance
- Successful compliance
- Streamline EU MDR Compliance Obligations
- Source Intelligence’s EU MDR Program
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