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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Aug 30, 2019
Europe
What is IVD/IVDR In Vitro Diagnostic (IVD) medical devices are intended for examining specimens of the human body to either provide information on the physiological state of the patient or to monitor therapeutic measures. They could also be used to define the...
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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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Jun 21, 2019
EU MDR/IVDR
European trade association, MedTech Europe, published a detailed plan. It aims to help the member states speed up and simplify the process of implementation of new MDR/IVDR regulations. The plan intends to assist states and national medical regulating authorities by...
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