Nov 17, 2022
EU MDR/IVDR
The new article describes in detail the aspects related to the responsibilities of authorized representatives as set forth under the existing framework, as well as the liability they could be subject to, and situations when they are allowed to initiate termination of...
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Nov 10, 2022
EU MDR/IVDR
The new article provides additional details regarding the aspects related to the responsibilities of authorized representatives. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC) responsible for medical...
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Oct 4, 2022
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...
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Sep 16, 2022
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...
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Sep 11, 2022
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,...
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