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...
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...
The article highlights the key points associated with the substantial changes to performance studies in the context of the new regulatory framework. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission...
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...
The new article highlights the aspects related to non-conformity which does not impose unacceptable risks to health and safety. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC) responsible for medical...
EU MDR/IVDR
