EU
The article describes in detail the approach to be followed in order to determine the regulatory status and applicable regulatory requirements.
Medical Devices
The General Safety and Performance Requirements (GSPR) are a crucial component of the European Union’s regulatory framework for medical devices and in-vitro diagnostic devices, specifically under the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746).
European Union
The article provides a general overview of the UK regulatory framework for medical devices.
Medical Devices
Post-market surveillance (PMS) is a critical component of the European Union Medical Device Regulation (MDR).
RegDesk News/Info
The article outlines the key points associated with the classification rules for medical devices.
