Nov 18, 2019
Europe
The Medical Device Coordination Group (MDCG) of the European Commission (EC) issued guidance on certain transitional provisions regarding European Union medical devices regulations. MDCG on Transitional Provisions The MDCG is a special advisory body of the...
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Oct 17, 2019
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), a special advisory body of the European Commission (EC) issued a detailed guidance on software classification according to the new medical device regulations: 2017/745 (MDR) and 2017/746 (IVDR). Medical Software Regulated...
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Sep 19, 2019
EU MDR/IVDR
Expert Panels: Functions and Features According to the new regulatory framework set forth by Medical Device Directive (MDR) and In Vitro Diagnostic Directive (IVDR), special expert panels should be designated to provide assistance to regulating authorities and...
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Jul 12, 2019
Europe
European medical regulating authority, the EC, recently published a new guidance on medical device vigilance systems covering issues related to the distribution of information between national competent authorities. The document, intended to clarify definitions, set...
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Jul 2, 2019
EU MDR/IVDR
European medical device regulating authority, the European Commission, issued two additional guidance. They expand on certain application aspects of Medical Device Regulation and in vitro Diagnostic Device Regulation. The new documents include important changes and...
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