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...
EU MDR/IVDR
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...
EU MDR/IVDR
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...
EU MDR/IVDR
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...
EU MDR/IVDR
The article provides an overview of the European regulatory requirements in the sphere of conformity assessment bodies and notified bodies set forth by the existing regulatory framework. In particular, the article addresses the matters related to the pre-assessment...
EU MDR/IVDR
The article provides an overview of the clarifications provided concerning solutions available during the temporary unavailability of the global European database. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body...
