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.
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...
EU MDR/IVDR
The Council of the European Commission concluded in a meeting on December 9th to address member states’ concerns over the challenges and issues in meeting current EU Medical Device Regulation (MDR) deadlines. Table of Contents Regulatory Background According to...
