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...
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...
The new article describes the actions to be taken by the parties involved upon completion of an on-site assessment. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for...
The new article provides additional details regarding the on-site inspection activities to be undertaken as a part of the designation process. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European...
The article describes in detail the regulatory procedures to be performed for an application for designation as a conformity assessment body under the new medical device regulatory framework. Table of Contents The Medical Device Coordination...