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, 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. To view the directive in draft format view EUMDR
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
The new EU MDR directive is still in consultation phase, with the finalization of the directive working towards Q1 2017. The proposed rollout is 3 years from publication (2020) and 5 years for in-vitro diagnostic medical devices (2022).
So what exactly will change is still to be confirmed, however it is believed that the final directive will include the following:
- Wider scope for EU legislation on medical devices – extended to include items such as implants for aesthetic purposes
- New Eudamed database on medical devices that will provide comprehensive information on products available on 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 traceability 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 labelling rules
- International guidelines to be incorporated into EU law.
Download our Whitepaper: EU MDR Labeling Compliance: Learning The Lessons From UDI