As a medicinal expert at one of the leading notified bodies of the EU, I’ve been involved in the assessment of medicinal files of many different device-drug combination products. These are devices that include ancillary medicinal substances, in which the device has the primary mode of action, and the medicinal substance has an additional beneficial effect. The ancillary medicinal substances range from small molecules to human blood derivatives and recombinant products.
Depending on the nature of the ancillary medicinal substance a consultation with a national competent authority or the EMA is required. Human blood derivatives and recombinant products are higher risk products and therefore require assessment by EMA. The consultation process for medical devices is comparable to filing a market application.
hVIVO plc (formerly Open Orphan plc) is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and long-standing client base of biopharma companies.