
Understanding the Post-Market Surveillance Requirements Under the EU MDR
Post-market surveillance (PMS) is a critical component of the European Union Medical Device Regulation (MDR).
Post-market surveillance (PMS) is a critical component of the European Union Medical Device Regulation (MDR).
The article outlines the key points associated with the classification rules for medical devices.
The article describes in detail the regulatory requirements for certain innovative medical devices.
Clinical evaluation is the cornerstone of the European Union Medical Device Regulation (MDR).
The introduction of the European Union Medical Device Regulation (MDR) represents one of the most significant changes in the history of medical device regulation in Europe.
The article provides an overview of the regulatory approach to be applied with respect to certain categories of innovative medical devices.