The EU-MDR creates significant regulatory challenges for drug-device combination product manufacturers since these products may be regulated either as medicinal products or medical devices, depending on their primary mode of action.
Understanding how to navigate regulatory challenges can have a significant impact on both the strategic planning of a manufacturer/developer and patient safety.
In particular, the approval process for manufacturers of integral combination products now requires an opinion from a notified body (NBOp) affirming the conformity of the device part to the applicable General Safety and Performance Requirements (Art. 117). This opinion must be included in the Marketing Authorisation Application submission and is critical to the approval pathway.
Article 117 applies to a wide range of products such as autoinjectors, inhalers, pre-filled nebulisers, pre-filled pens, pre-filled syringes and transdermal patches.
Evnia has summarised the types of combination products and their respective regulatory pathways in a short video. Watch it here.
