Article | June 14, 2019

A New Reality: EMA Published First Guidance On New MDR/IVDR Rules For Certain Devices

Source: ICON Plc
Changes In Regulatory Requirements For Biosimilar Development In India

The increasing pace of innovation and blurring boundaries between pharma and device products have led to new drug-device combination products and the need for updated regulatory guidances.

As a result, the European Medicines Agency’s (EMA’s) Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and the European Commission published a Q&A document detailing information for products that need both the drug and the device components to function. This document is the first in a series of guidances to help manufacturers prepare for compliance under the new EU MDR and IVDR rules.