EU MDR/IVDR
The article highlights the key points to be considered when determining the regulatory nature of products considered general medical devices. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for...
EU MDR/IVDR
The new article provides an overview of the medical device classification rules adopted in the European Union and highlights the key points associated thereto. Table of Contents The Borderline and Classification Working Group (BCWG), a subgroup of the Medical Device...
EU MDR/IVDR
The new article outlines considerations related to the activities carried out by notified bodies concerning medical devices intended to be marketed and used in the EU. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European...
EU MDR/IVDR
The new article describes the matters related to the re-assessment of designated conformity assessment bodies. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC) responsible for medical device regulations,...
EU MDR/IVDR
The article provides additional details regarding the matters related to the notification made in the context of designation and the appropriate publication. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission...
EU MDR/IVDR
The new article describes the way the designating authority will take its decision on the designation of an applicant entity. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible...
