Can I read Manufacturer Obligations under MDR 2017/745 on EtoBox?

Manufacturer Obligations under MDR 2017/745 by AR is a document available to read on EtoBox.

What is Manufacturer Obligations under MDR 2017/745 about?

The document outlines the obligations of manufacturers under the Medical Device Regulation (EU) 2017/745, defining a manufacturer as a person or entity responsible for the design, manufacture, or refurbishment of medical devices. Key responsibilities include risk management, clinical evaluation, maintaining technical documentation, and ensuring compliance through a designated Person Responsible for Regulatory Compliance (PRRC). Additionally, manufacturers must communicate issues with products to relevant ec

Author

AR

Language

EN