Aug 19, 2022
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...
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Aug 16, 2022
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...
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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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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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