WHAT IS EU MDR?
The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. It is to have a fundamental revision in 2017 to better identify medical devices products and improve transparency through standard data, technological advances and the establishment of an EU database (Eudamed). Similar to the FDA’s UDI, EU MDR will establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation.
EU MDR is relevant to any organization producing or supplying medical device products to Europe.
Until now, different European countries have interpreted and implemented the directive in different ways. By revising the directive EU MDR will enforce:
- Stricter pre-market control of high-risk devices at an EU level
- The inclusion of certain aesthetic products which present the same characteristics and risk profile as equivalent medical devices
- A new risk classification system for diagnostic medical devices based on international guidance
- Improved transparency through the establishment of a comprehensive EU database of medical devices (Eudamed)
- Device traceability through the supply chain from its manufacturer through to the final user
- An EU-wide requirement for an 'implant card' to be provided to patients containing information about implanted medical devices
- the reinforcement of the rules on clinical data and clinical studies on devices
- Manufacturers to collect data about the real-life use of their devices
- Improved coordination between EU Member States
EU MDR’s IMPACT ON LABELING:
The new EU MDR/IVDR regulation puts labeling in a prominent position. It is critical for regulatory, labeling and operational professionals to gain a clear understanding of the impact of the new regulations on labeling.
PRISYM ID labeling solutions provide organizations with complete label integrity to meet the strictest compliance requirements for FDA & EU regulations, including the upcoming EU MDR.
Implementation of the EU MDR can be complex and challenging. As you implement, it is important to understand if your plan is going in the right direction, or not. Let us go through the key steps that your EU MDR project must include: