February 2023

New Features and Improvements in EUDAMED

Posted on February 24, 2023 By MDSS

EUDAMED Production v 2.10 has been released with several new features and improvements. Are you ready for the latest and greatest version of EUDAMED Production? Look no further than version 2.10, which comes with a range of exciting new features and improvements. In this post, we’ll provide yo...

Key Terms in the Medical Device Regulation

Posted on February 16, 2023 By MDSS

Key Terms and Concepts in the Medical Device Regulation – Vigilance The vigilance requirements under the EU’s medical device regulations can be complex and confusing. To help you navigate this landscape, the Medical Device Coordination Group (MDCG) has released a guide to key terms and c...

MDCG Guidance Document on IVD classification

Posted on February 15, 2023 By MDSS

MDCG guidance document on IVD classification If you’re involved in the manufacture or sale of in vitro diagnostic medical devices (IVDs) in the European Union, you’ll want to familiarize yourself with the MDCG guidance document on IVD classification. This document (second revision), deve...

New Features and Improvements in EUDAMED

Key Terms in the Medical Device Regulation

MDCG Guidance Document on IVD classification

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