EU
The article provides an overview of the provisions of a guidance document and highlights the key points to be taken into consideration by medical device manufacturers (software developers).
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 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...
MDCG
The article provides an overview of the revised guidance document addressing the classification rules. Table Of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for the medical devices regulatory framework,...
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...
EU MDR/IVDR
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...
