Integral DDCs are products which include:
- devices that when placed on the market or put into service incorporate, as an integral part, a substance that, if used separately, would be considered as a medicinal product, provided that the action of the substance is principal (based on Article 1(8) MDR).
- devices intended to administer a medicinal product, where they form a single integral product intended exclusively for use in the given combination and which is not reusable (based on Article 1(9) MDR). Typically, these devices have measuring, metering or delivery functions.
Non-integral DDCs are those DDCs for which the two or more separate components (i.e. medicinal product(s) and device(s)) are not physically integrated during manufacturing, but where the medicinal product and the specific device(s) are combined for administration.
Devices in non-integral DDCs are co-packaged and supplied along with the medicinal product, or where the product information of the medicinal product refers to a specific device to be used with the medicinal product, but the device is obtained separately.
The content of the underlying definitions and regulatory concept (e.g. which devices must be CE marked and which not) remains the same, but article 117 (2nd paragraph) defines a major hick-up and possible time-consuming addition compared to Council Directive 93/42/EEC (#MDD):
“Where, if the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements (GSPR) set out in Annex I to that Regulation issued by a notified body designated in accordance with that Regulation [MDR] for the type of device in question.”
What does that mean?
Article 117 basically says that, although the device itself is regulated as a medicinal product and therefore not to be CE marked, a notified body needs to be involved to provide evidence (“opinion”) about compliance with the #GSPR.