Regulatory
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.
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.
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.
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.
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.
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.
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.
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.
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.
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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