Regulatory
European Union's Medical Device Regulation
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.
Medical Device Regulation Resources .
EU MDR: How to Prepare for the Upcoming Changes in Regulation
6 Tips for Successful Transition to the EU MDR
Uncertainty Regarding EU MDR Underscores Importance of Certification Preparation
EU MDR: How Will Europe's New Device Regulation Affect Software?
Q&A: Device Manufacturers’ FAQs on the EU’s 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.
Common Questions about the EU's med device regulation.
What is the difference between the European Union’s (EU) Medical Device Directive (MDD) and the Medical Device Regulation(MDR)?
The EU MDR is set to replace the MDD in May 2021. The newer regulation is intended to increase the safety, transparency and usage of medical devices sold in the EU.
What is the relationship between the European Union’s (EU) Medical Device Regulation (MDR) and the ISO 13485?
While the EU MDR doesn't specify the conformity assessment route a manufacturer must use, most device makers will use ISO 13485:2016. However, compliance with ISO 13485 doesn't guarantee that a medical device will be fully compliant with the EU MDR.
What is the European Union’s (EU) Medical Device Regulation (MDR)?
The EU MDR replaces the Medical Device Directive (MDD) on May 2021 for all medical devices sold in the EU. The new regulation is meant to increase transparency and the stringency of the approval and usage of devices while also improving patient safety and outcomes.
What is new about the European Union’s (EU) Medical Device Regulation (MDR)?
The EU's new MDR increases premarket conformity requirements for all medical devices sold in the EU. The regulation also has more stringent risk assessment requirements, allows for greater tracking of device performance and safety, reclassifies a device based on its purpose.
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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