Jan 16, 2023
EU MDR/IVDR
The article provides an overview of the guidance document explaining how Article 97 MDR should be applied to legacy devices. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices,...
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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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