The European Union Medical Device Regulation (EU MDR) - Regulation (EU) 2017/745 - is the regulatory framework that governs the production, certification, and distribution of medical devices in the EU. Implemented in May 2021, it replaces the former Directive 93/42/EEC (MDD) to enhance patient safety and industry transparency.

Yes, EU MDR is mandatory for all medical device manufacturers who want to market their products in the European Union. MDR certification under Regulation (EU) 2017/745 is essential to obtain CE marking and access the European market.

What are the key EU MDR regulation requirements?

The MDR regulation imposes strict requirements on manufacturers including enhanced clinical evidence, rigorous post-market surveillance, comprehensive risk management, and complete traceability of medical devices. MDR training is strongly recommended to ensure full compliance of your organization with EU MDR requirements.

What is the difference between ISO 13485 and EU MDR?

ISO 13485 is an international quality management system standard for medical device manufacturers, while EU MDR is a European legal regulation. ISO 13485 focuses on quality management processes, whereas EU MDR defines legal requirements for safety, clinical evidence, and market access in Europe. Both standards are complementary.

What is the difference between the FDA and EU MDR?

The FDA (Food and Drug Administration) regulates medical devices in the United States, while EU MDR applies in the European Union. These are two separate regulatory systems with different requirements, approval processes, and certification standards, although their common goal is to ensure the safety and effectiveness of medical devices.

The European Union Medical Device Regulation (EU MDR) - Regulation (EU) 2017/745 - is the regulatory framework that governs the production, certification, and distribution of medical devices in the EU. Implemented in May 2021, it replaces the former Directive 93/42/EEC (MDD) to enhance patient safety and industry transparency.

Yes, EU MDR is mandatory for all medical device manufacturers who want to market their products in the European Union. MDR certification under Regulation (EU) 2017/745 is essential to obtain CE marking and access the European market.

What are the key EU MDR regulation requirements?

The MDR regulation imposes strict requirements on manufacturers including enhanced clinical evidence, rigorous post-market surveillance, comprehensive risk management, and complete traceability of medical devices. MDR training is strongly recommended to ensure full compliance of your organization with EU MDR requirements.

What is the difference between ISO 13485 and EU MDR?

ISO 13485 is an international quality management system standard for medical device manufacturers, while EU MDR is a European legal regulation. ISO 13485 focuses on quality management processes, whereas EU MDR defines legal requirements for safety, clinical evidence, and market access in Europe. Both standards are complementary.

What is the difference between the FDA and EU MDR?

The FDA (Food and Drug Administration) regulates medical devices in the United States, while EU MDR applies in the European Union. These are two separate regulatory systems with different requirements, approval processes, and certification standards, although their common goal is to ensure the safety and effectiveness of medical devices.

Medical Device Change Notification

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The purpose of this medical device change notification guide, developed by GMED, is to provide guidance on when and how to notify your notified body of proposed changes to a medical device and/or quality management system.

As part of its ongoing efforts to improve certification practices and prepare for the regulatory changes introduced by Implementing Regulation (EU) 2026/977, GMED has updated its change management process.

To support manufacturers in implementing this updated approach, GMED has revised its change management guide, which serves as a reference for understanding and applying the new process and its requirements for medical device change notification.

guide en may 26

The guide includes:

Key definitions to support the appropriate categorization of proposed changes
A detailed overview of the stages of the change management process
A description of the different categories of changes
A practical categorization tool with numerous examples to help companies evaluate and classify their change projects

Please review this guide carefully and contact your Certification Project Manager should you have any questions regarding the implementation of this updated process.

Changes to devices and/or quality management system: When and how to report changes?

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