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.

MDCG Publishes IVDR Guidelines MDCG 2022-6

MDCG Publishes IVDR Guidelines MDCG 2022-6

MDCG publishes IVDR surveillance guidelines MDCG 2022-6, regarding the transitional provision under Article 110(3) of the IVDR. The aim of this guidance document is to provide clarification on the concept of “significant changes in the design and intended purpose” under IVDR Article 110(3).