• Andrew Wu

7 Questions about the European MDR Answered

This post was published by Jon Speer, the Founder and VP QA/RA at Greenlight Guru.


The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.

If your company was already compliant with the Medical Devices Directive (MDD), don't be fooled into complacency - the MDR represents brand new regulations with a lot of changes.

As a starting point for medical device companies, we've created this article where we answer the seven of the most important questions about the new MDR.

We'll cover why the old regulations needed an update, the structure of the new MDR document, and some of the latest requirements that medical device companies need to be aware of.

(Click here to read more)

Please contact us at if you have any questions.

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#MedicalDeviceRegulationMDR #MedicalDevicesDirectiveMDD #SaMD #UniqueDeviceIdentificationUDI

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