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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New EU guidance includes more information for drug-device combination product makers who are worried about how to comply with requirements being introduced for pharmaceuticals under the new EU medical device rules.
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.