Jul 20, 2022
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...
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Apr 25, 2022
Asia
The new article provides additional details regarding the specific aspects covered by the scope of the new regulation on clinical trials for medical devices. Table of Contents The new regulation related to clinical trials for medical devices has been...
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Apr 18, 2022
Asia
The new article provides additional details regarding the new regulation on clinical trials for medical devices published recently in Turkey. In particular, the article addresses the matters related to the reports associated with clinical trials and also outlines the...
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Mar 25, 2022
EU MDR/IVDR
The new article addresses certain specific aspects related to post-market surveillance in the context of medical devices certified under the Directives. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the...
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Mar 23, 2022
EU MDR/IVDR
The article provides an overview of the new guidance document issued by the MDCG about surveillance in the context of MDR transitional provisions. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European...
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