EMA Issues Guidance On Medical Devices That Are Integral To Pharma Products
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.
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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.
Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?