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The European Medicines Agency’s Committee on Advanced Therapies (CAT) has issued a work plan, which is intended to assist in the implementation of the Medical Devices Regulation (MDR), as well as the In Vitro Medical Devices Regulation (IVDR). The plan includes the establishment of a medical devices focus group. This group will be the point of contact regarding issues related to medical devices, and in vitro medical devices that arise in the context of advanced therapy medicinal products.
The plan provides that the medical device focus group will be composed of CAT members, alternates, and experts with medical device competence.
Other key objectives of the work plan regarding the upcoming application of the MDR and IVDR include:
Other initiatives proposed in the work plan include the following:
Authored by Elisabethann Wright and Vicky Vlontzou