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:

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