Nov 23, 2022
EU MDR/IVDR
The new article highlights the key points related to a change of authorized representative, as well as the ones related to responsible persons and marketing surveillance. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European...
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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 23, 2022
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...
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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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