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Tag: EU MDR 2017/745

Cybersecurity Threat Model Implementation: FDA Requirements

The Food and Drug Administration (FDA) plays a pivotal role in safeguarding public health through the regulation of medical devices, ensuring that they are...

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Trend Reporting According to EU MDR and IVDR

In this article, we will go through the requirements for Trend Reporting, that are summarized within Article 88 of the EU MDR ,and  Article 83...

MDCG : Medical Device Coordination Group

MDCG – Medical Device Coordination Group is a new entity that has been introduced with the EU Medical Device Regulation 2017/745 and In-vitro Diagnostic...

Medical Device Definition according to EU MDR 2017/745

Medical Device definition has been changed with the new EU MDR 2017/745 and the impact of this change over manufacturers of “borderline” devices is...

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