Functions and Effects of European Standards: The Final Study

Functions and Effects of European Standards: The Final Study

In 2021, the European Commission published its roadmap for a new standardization strategy. The aim of the new strategy is to address the challenges facing the European standardization system. During an 18-month period, different categories of stakeholders from EU and EFTA Member States were consulted as part of this roadmap. The main results are now published in this study.

Extension of Delegated Powers MDR & IVDR?

Extension of Delegated Powers MDR and IVDR?

Extension of Delegated Powers MDR and IVDR? – The European Commission wants to extend its delegated powers for five years. This is to be able to amend the MDR and IVDR where the text of the regulations allows.

EU MDR 2017/745 What Changed?

EU MDR 2017/745 What Changed in regard to the Medical Device Directive and how to implement them in your current quality management system?

The new medical device regulation, EU MDR 745/2017, has several additional criteria in regard to previous legislation. This new regulation also has a stronger connection to EN ISO 13485:2016. What modifications have been made to the prior medical device regulation, and how must you implement these changes in your current quality management system?