Medical Devices: Are you ready for EU MDR?

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26 February 2024 - 18:30, by , in Medical Device, News, Comments off

The deadline for manufacturers to comply with European Union Medical Device Regulation is fast approaching. On May 26th the EU MDR comes into effect, introducing a new set of rules designed to ensure the highest quality of medical device manufacturing.

What is EUMDR?

EU MDR is a regulatory standard that harmonised medical device regulation across all 27 EU member states. It applies to any manufacturer that wishes to sell medical devices in the EU.

Key Date

May 26th 2024

Do you sell medical devices in the UK? Medical Devices manufacturers require a UK Representative to sell in the UK.

Why the Deadline Matters

Any manufacturer that fails to comply with the EU MDR by May 26th deadline cannot legally sell their devices in the EU. Manufacturers have two options comply with EU MDR by this date or withdraw their product from the market.

How we can help

As the deadline approaches, manufacturers must assess their current position and identify compliance gaps. Once this gap analysis is complete work can begin to bring the company and products into compliance with EU MDR. With less than 3 months to go the time to act is now.

Get Started

First step to compliance is to get in touch and talk to an advisor.

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