EUROPEAN MEDICAL DEVICE REGULATIONS – 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
Similar to the FDA’s UDI, MDR will establish a robust, transparent, predictable, and sustainable regulatory framework for medical devices to ensure a high level of health and safety while supporting innovation.
EU MDR is significant 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 trace-ability 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
- 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 the EU Member States
The proposed rollout is 3 years from publication (2020) and 5 years for in-vitro diagnostic medical devices (2022). The 2020 deadline is in the process of being delayed for one year until May 26, 2021, due to the COVID-19 pandemic. This will allow Medical Device manufacturers to defer MDR compliance activities to concentrate on needed production.
- Wider scope for EU legislation on medical devices – extended to include items such as implants.
- New Eudamed database on medical devices that will provide comprehensive information on products available in the EU market
- Stronger European supervision of independent assessment bodies by national authorities
- Assessment bodies to have more powers to ensure thorough testing and regular checks on manufacturers
- Better trace-ability of medical devices throughout the supply chain –enabling a swift and effective response to safety problems
- Stricter requirements for clinical evidence to support assessments of medical devices
- Updated classification rules dividing IVDs into 4 different risk categories and health & safety requirements, including labeling rules
- International guidelines to be incorporated into EU law.