2021 has been a very busy time for the medical device sector around the world. Of particular importance is the EU MDR, due to be implemented in 2020 but postponed until 26 May 2021 due to the COVID-19 pandemic. While the MDR will serve to strengthen the existing regulatory landscape for medical devices in Europe, Brexit has presented a new set of obligations for medical device manufacturers.
Meanwhile in China, Order No. 739 on the Supervision and Administration of Medical Devices became effective on 1 June 2021. The in-vitro diagnostic (IVD) regulation remains at draft stage, and some supplementary regulations have been proposed.
This white paper focuses on the latest regulatory developments for medical devices in the EU, UK and China, providing an overview of key updates between January and June 2021.
Author: Amy Chen (Pei Yu Chen), Regulatory Consultant, Compliance & Risks
Amy is a Regulatory Consultant with Compliance & Risks, specializing in consumer products compliance, focusing on China, Taiwan, and other Asian countries.
She helps product manufacturers to identify and understand the regulations in place in the markets to which they sell by helping them to map their obligations with regard to product safety (chemicals, EMC, radio frequency), labeling, energy efficiency, waste and packaging.
Amy is a native Chinese speaker and has a Master of International Commercial Laws from the University of Limerick, and a Bachelor of Law degree from University College Cork.