Drug-device combination products

The MDR provides a clear framework for determining the appropriate regulatory pathway for products that combine a medical device and a medicinal product. If the sole intended purpose of a medical device is to administer a medicinal product, forming a single integral product that is not reusable, this combination will be regulated as a medicinal product. In this scenario, the medicinal product's regulatory framework applies, but the relevant general safety and performance requirements of the MDR (Annex I) must still be met for the device component. 

In other cases, where a medicinal product and a medical device intended to administer it do not form a single, integral product and can be used independently of each other, each component is regulated separately: the medical device is regulated under the MDR, while the medicinal product is regulated under the medicinal product regulations. 

The different regulatory pathways also apply to medical devices that incorporate a medicinal substance as an integral part. Where the action of the medicinal substance in this integral product is principal relative to the device, such a combination product will be regulated as a medicinal product. However, the relevant general safety and performance requirements in Annex I of the MDR still apply to the safety- and performance-related features of the device. 

If the principal intended action of such an integral product is achieved by the medical device, the entire product is regulated under the MDR. However, specific requirements apply to this type of product, particularly regarding the medicinal product component. One key requirement is the necessity of consultation with a medicinal product agency.

If the device is CE marked, the results of the conformity assessment shall be included in the marketing authorization dossier of the medicinal product, including any variation dossiers. This means the conformity assessment results must cover the relevant general safety and performance requirements set out in Annex I of the MDR. These results should be documented in the manufacturer's EU declaration of conformity or on the valid CE certificate issued by a notified body. 

However, if the dossier does not include this information and if the conformity assessment of the device, if used separately, would require the involvement of a notified body, an opinion on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I must be provided by a notified body designated for the type of device, in accordance with the MDR.

When a medical device and a medicinal product are co-packaged (i.e. packed together into a single pack, such as a carton, by the Marketing Authorization Holder), the medical device must be CE marked in accordance with the MDR. This applies to devices such as spoons, measuring cups, inhalers, or spacers included within the secondary packaging of the medicinal product. The CE marking ensures that the medical device complies with the necessary safety and performance requirements, allowing the combined product to be legally marketed. Relevant information for the use of the co-packaged device, especially if necessary for the intended use of the medicinal product with the device, should be included in the appropriate sections of the medicinal product package leaflet and SmPC, as applicable. Additional information on medical devices that should be provided in the registration dossier of the medicinal product is described in the EMA Guideline.