Requirements and information relating to combination products (medicinal products with a medical device component) in the form Application for authorisation / variation, human medicinal products

If a medicinal product with a medical device component (combination product) is submitted for authorisa-tion, a new requirement is the inclusion, in the form Application for authorisation / variation, human medicinal products, of information about the documentation on the medical device. A distinction is made as to whether a non-integral or an integral combination product is involved.

10.07.2017 - In a non-integral combination product, the medical device component is included in the packaging or provided separately; the product must also bear a CE mark and the corresponding declaration of conformity. In an integral combination product, the medicinal product component and the medical device component form an integral unit that is designed exclusively for use in this combination, and the product may not be reused (e.g. prefilled syringes, autoinjectors, preloaded powder inhalers, prefilled infusion pumps, etc.). If there is no CE mark on the medical device component in this group of products, the applicant must demonstrate that the medical device component satisfies the relevant requirements of Annex I of the European Medical Devices Directive 93/42/EEC (usually performance and safety). The applicant must also demonstrate, both for non-integral and integral combination products, that the medical device component is suitable for the specific medicinal product in the existing combination (e.g. dosing accuracy, compatibility, etc.).

In cases where the submitted application concerns an integral or non-integral, innovative and complex com-bination product (e.g. electronically controlled injector, chip in a tablet for monitoring patient compliance), the suitability of the medical device component in the existing combination with the medicinal product must be demonstrated in an additional expert report. This could take the form, for example, of a report by a conformity assessment body (e.g. for integral combination products without CE marking) or some other type of expert opinion and/or the corresponding Assessment Report of an EU drug regulatory authority.

The preconditions specified above are also explained in section 2.5.14 of the Guidance document Formal requirements.