EU drug and device legislation: What you need to know

After a year-long delay due to the COVID-19 pandemic, the EU Medical Devices Regulation (EU MDR) is set to come into effect on May 26th 2021. Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) will come into effect May 2022 after a five year transition period. These Regulations have a staggered transitional period with some aspects becoming legally binding after 6 months of entry into force. Both of the new regulations retain existing principles and components but represent a significant development and strengthening of the regulatory system for medical devices in Europe and will replace the original Directives which have been in place for over 25 years. Zsolt Kocsis, Cromos Pharma’s Head of EU Operations explains what the new regulations mean in this video presentation: For more information about how Cromos Pharma can support your clinical program please email us at inquiry@cromospharma.com

 

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Cromos Pharma proudly supports the Right2hope nonprofit platform, empowering patients to explore treatment options beyond traditional clinical trials. Through an intuitive, AI-supported matching algorithm, Right2hope connects patients with the most relevant expanded access, compassionate use, and right-to-try programs.