It can be challenging to determine the classification of your product under EU MDR 2017/745. To correctly understand if your product falls under the medicinal product directive or medical device regulation, you first need to evaluate the (PMOA) Primary Mode of Action.
A ‘medical device’ is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
A medicinal product example could be wound treatment product for delivery of an antimicrobial product whereby the PMOA is either (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action or to making a medical diagnosis. For example, a wound dressing with an antimicrobial coating or a heparin-coated catheter are medical devices per the definition in Article 2 of the EU MDR 2017/745.
Devices which incorporate an ancillary medicinal substance or combination products, such as drug-eluting stents or metered-dose inhalers, contain a medical device component which acts as the delivery system of the integral drug element. To be considered a device-drug and fall under the EU MDR, the PMOA should be achieved by the device part with the substance having an ancillary action. EU MDR Article 1 Subject Matter and Scope subpoint (8) states:
“Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation”.
- EU Medical Device Regulation (MDR) 2017/745
- EU In Vitro Diagnostics Regulation (IVDR) 2017/746
- MEDDEV guidelines
Medicinal Products Directive:
- Regulation 726/2004: Establishment of European Medicines Agency (EMA)Directive 2001/83/EC Medicinal products for human use
- Amended Directives 2002/98/EC; 2004/24/EC and 2004/27/EC.