Regulatory
The European Union's Medical Device Regulation (MDR)
Medical device manufacturers must recertify their devices under the Medical Device Regulation (MDR) by May 26, 2020. Find out what you need to do to ensure your devices are recertified by the compliance deadline.
Resources to help you successfully transition your company's devices to the Medical Device Regulation (MDR).
EU MDR: How to Prepare for the Upcoming Changes in Regulation -INDUSTRY BRIEF
Your comprehensive guide to all the changes medical device manufacturers will see with the Medical Device Regulation (MDR) and how to best prepare to recertify your devices by the May 26, 2020 deadline.
6 Tips for Successful Transition to the EU MDR - GxP Lifeline BLOG POST
Learn six important steps manufacturers can take to prepare for recertification against the Medical Device Regulation (MDR).
Uncertainty Regarding EU MDR Underscores Importance of Certification Preparation - GxP Lifeline BLOG POST
Learn from a med dev industry expert about the latest developments, including the lack of designated Notified Bodies, and tips on how to prepare your company for the MDR.
EU MDR: How Will Europe's New Device Regulation Affect Software? - GxP Lifeline BLOG POST
Find out how the Medical Device Regulation's (MDR) software requirements will impact your quality management system (QMS).
EU MDR Device Manufacturers FAQ's on the EUs Medical Device Regulation
Two experts in the medical device and regulatory fields answer some of the most common questions manufacturers have about the Medical Device Regulation (MDR).
How Will Regulations Change With Medical Device Regulation (MDR)?
More Premarket Regulatory Obligations
The MDR increases premarket conformity requirements. Manufacturers will need to implement a system process to continuously aggregate and analyze clinical data that verifies a device's safety and efficacy.
More Stringent Risk Management Requirements
Risk management with MDR will require ongoing, systematic processes for analysis through a device's life cycle, including regular updates and identifying the risks of potential hazards and device misuse.
Greater Tracking for Device Performance and Safety
The European Database for Medical Devices (EUDAMED) will monitor device data for pre- and postmarket surveillance. Manufacturers need to report all device-related incidents, accidents and deaths in EUDAMED.
Reclassifications Based on a Device's Purpose
The new MDR changes some classifications, raising some devices to a higher risk category based on their purpose, i.e., devices that incorporate nanotechnology, orthopedic implants, surgical meshes and some software.
Learn how to best navigate the EU MDR.
Don't delay your preparations. Find out the specifics of what you need to do to recertify your devices under the new regulation.
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