Medical Devices Incorporating Medicinal Substances

The regulatory framework for devices incorporating ancillary medicinal substances as an “integral part” is described in Article 1, Paragraph 8, of Regulation (EU) 2017/745:

• When the action of the medicinal substance is ancillary, the product is subject to the medical device regulation and must have a CE marking in accordance with the Regulation (EU) 2017/745. 

Medical devices incorporating medicinal substances are class III devices under Rule 14 of Appendix VIII of Regulation (EU) 2017/745 that require a specific assessment procedure. Because of their complexity and risk, the assessment of medical devices incorporating medicinal substances is subject to additional requirements.

After assessing the usefulness of incorporating the substance in the device, the notified body seeks a scientific opinion on the quality and safety of the substance as well as the benefit-risk profile of adding it to the medical device. This is the consultation procedure with a competent authority designated by the Member States under Directive 2001/83/EC for the evaluation of medicinal products or with the EMA.

The competent authority consulted has 210 days, from the time of receiving all the necessary documentation, to issue an initial scientific opinion. The competent authority takes into account the evaluation of the usefulness performed by the notified body, as well as the manufacturing procedure. This time period is reduced to 60 days for an additional opinion on a change affecting the medicinal substance.

This procedure is described in Regulation (EU) 2017/745 on medical devices with Article 52, Annex IX (Section 5.2) and Annex X (Section 6).

Beyond the statutory time periods of 210 or 60 days, additional time periods may be needed for the admissibility phase of the dossier and the processing of any additional applications, depending on the procedures of each competent authority.

GMED has extensive experience with a team specialized in assessing medical devices incorporating medicinal substances, their various features and characteristics: analyzing the proof of usefulness of adding the medicinal substance, and managing consultations by communicating with the competent authorities for the quality & safety component and analyzing the benefit-risk profile.