Germany's DEKRA Named As Third MDR Notified Body In EU
Executive Summary
Another notified body, DEKRA based in Germany, has been added to the list of MDR-accredited bodies. But time is ticking, more are urgently needed and experts are taking to social media to voice their concerns.
You may also be interested in...
EU Regulatory Roundup, September 2023: Dismantling Regulatory Barriers To Medtech Innovation
The call for more to be done about the EU’s regulatory hurdles to innovation, as well as for improvements to governance, has now grown to a crescendo. While the EU looks at how best to move forward, innovation in the UK is benefiting from greater regulatory freedoms.
Commission Text Clarifying Timelines For Annex XVI Devices May Leave Companies Dazed
The revised timelines around products generally used for aesthetic purposes, a small subset of products falling under the Medical Device Regulation, create their own microsphere of complexity.
Report on Generating And Assessing Evidence To Optimize MDR And IVDR Due In 2024
Recent meeting at Ernst &Young in Brussels outlines steps ahead and likely timelines for gathering information instrumental in shaping recommendations for the future of the MDR/IVDR and their governance structures.