Medical Device Regulatory Guide

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Regulation 1025/2012: Adapting for Future Standards & #MDR/#IVDR Support

Regulation 1025/2012 on European standardisation, which outlines the guidelines for the EU's standardisation policy, is currently under review for potential updates. Since its inception in October 2012, there have been significant shifts in the standardisation landscape. This initiative aims to assess if the existing Regulation is equipped to address the evolving global challenges, safeguard the public, and bolster the green and digital transformation. Additionally, it might be worth examining if the Regulation is aptly designed to support #MDR and #IVDR, especially considering the delayed progress in harmonised standards for these regulations.

 

🔗 Original:  https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13446-European-standardisation-evaluation_en