EMA Issues Guidance On Medical Devices That Are Integral To Pharma Products
Executive Summary
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.
You may also be interested in...
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.
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.