Regulators Urged To Avoid ‘Conflicting’ Clinical Requirements For Drug-Device Combinations In EU
EU regulators are being urged to get their skates on and publish guidance on new clinical requirements that will kick in soon for integral drug-device combination products.
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The Medical Devices Regulation (MDR) is the vehicle to clarify the role of EU notified bodies in medicinal products with integral medical devices, such as pre-filled syringes. Now, guidance from the EMA on the MDR shows how the pharma and device sectors are working increasingly collaboratively.