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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Oct 20, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the applicable classification rules. At the same time, the MDCG emphasizes that the document...
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Jul 2, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a Q&A document dedicated to the regulatory requirements for registration in EUDAMED, the new EU-wide database, of actors other...
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