---
title: 8 Questions about the European MDR Answered - Rook Quality Systems
description: 8 Questions about the European MDR Answered Rook Quality Systems Click here to learn more!
---

[Blog - Rook Quality Systems ](https://rookqs.com/blog)

# [8 Questions about the European MDR Answered - Rook Quality Systems](https://rookqs.com/blog/7-questions-about-the-european-mdr-answered)

 Written by [Andrew Wu](https://rookqs.com/blog/author/andrew-wu) | Apr 30, 2019 12:44:30 PM

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

The [European Medical Device Regulation (MDR)](http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2017:117:TOC) 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](https://www.greenlight.guru/blog/top-100-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)](http://www.mdss.com/pdf/MDD93_42EEC.pdf), 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, this article answers some of the most important questions about the new MDR.

[READ THE ARTICLE](https://www.greenlight.guru/blog/7-questions-about-european-mdr-answered)

Please contact us at info@rookqualitysystems.com if you have any questions.

**Sponsored by **

[#MedicalDeviceRegulationMDR](https://rookqs.com/blog/hashtags/MedicalDeviceRegulationMDR) [#MedicalDevicesDirectiveMDD](https://rookqs.com/blog/hashtags/MedicalDevicesDirectiveMDD) [#SaMD](https://rookqs.com/blog/hashtags/SaMD) [#UniqueDeviceIdentificationUDI](https://rookqs.com/blog/hashtags/UniqueDeviceIdentificationUDI)

[View full post](https://rookqs.com/blog/7-questions-about-the-european-mdr-answered)

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