EU Finalizes New Medical Device Regulation

A Q1 Productions 2017 White Paper

CHAPTER ONE: QUALITY MANAGEMENT SYSTEMS

The MDR contains explicit requirements for manufacturers to establish, implement, and manage a quality management system (QMS). While ISO 13485 is not required under the MDR, it is the recognized industry standard for comprehensive product design and manufacturing and can be implemented concurrent to the Regulation. An effective QMS must contain risked-based decision making processes and procedures for complying with evolving regulations, while monitoring delegated acts that might change the essential requirements.

To read more about the aspects that the quality management system shall address, download our whitepaper.

The six topic areas we will cover include changes to the following:

Clinical
Notified Body
Quality Management
Supply Chain
Surveillance and Vigilance
Technical Files

This paper looks to provide a summarized overview of the provisions within the regulation which will impact medical device manufacturers—from CE marking and technical document management to quality management systems.

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