Drug with device Component
Article 117 of the new Medical Device Regulations - MDR, in effect and applicable May 2020, makes an Amendment to Directive 2001/83/EC. This affects pharmaceutical products combined in a single, integral product.
The device element of the medicinal product needs to conform with medical device requirements and a Notified Body opinion must be incorporated into the marketing authorization application for the Medicinal Product.
Device with drug Component
Where a medical device incorporates an ancillary drug substance, the manufacturer must compile a dossier describing the quality, safety and usefulness of the drug substance to be submitted to the competent authority by the Notified Body for evaluation.
SRS can guide you in the process for your combination product