Rx

Regulatory

The European Union's Medical Device Regulation (MDR)

Are You Prepared to Transition Your Medical Devices to Europe's New 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.

How Will Regulations Change With Medical Device Regulation (MDR)?

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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.

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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.

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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.

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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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