Drug-Device Combinations

Please feel free to contact me to discuss how we can support you.

Mail: Anki@srs.se

Phone: +46 8 544 767 91

Drug with Device Component

Article 117 of the new Medical Device Regulations - MDR, in effect and applicable from May 2021, makes an Amendment to Directive 2001/83/EC. This affects pharmaceutical products combined with a medical device 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 has the capacity to guide you through the process for your drug-device combination product

Contact