EU
The article describes in detail the approach to be followed in order to determine the regulatory status and applicable regulatory requirements.
European Union
The article provides a general overview of the UK regulatory framework for medical devices.
Swissmedic
The article outlines the approach to be applied with respect to legacy medical devices in the context of transitional provisions.
EU MDR/IVDR
This article highlights the importance of GSPR compliance for obtaining medical device approval in the European Market. Table of Contents The European Union (EU) has implemented stringent regulations and requirements for the approval and launch of medical devices...
EU MDR/IVDR
Medical devices are an integral part of healthcare, and their safety and efficacy are critical to ensure patient well-being. In 2017, the European Parliament and Council adopted the new Medical Devices Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) to...
