Article 117 - Approaches for Integral Drug-Device Combination Product Platforms

3/22/2022 14:30 - 15:00

The MDR Article 117 introduces a new requirement that a Notified Body Opinion (NBOp) must accompany regulatory documentation for an integral drug-device combination (iDDC) product being submitted to National Competent Authorities (NCAs) or EMA.

In practice, many Marketing Authorization Holders use the same device constituent parts for various medicinal products. However, since the intended use, the user(s) and the environment of the medicinal product are different, a new NBOp is required for an already approved iDDC.

This session will highlight possible approaches and concepts to address such cases. Platform examples will include prefilled syringes and autoinjectors but the take-aways should be equally applicable to other types of iDDC.

Beat U. Steffen, Founder & CEO , Confinis AG