Products combining a medicinal product and a medical device are subject to a specific regulatory treatment. Article 1(8) and (9) of the MDR defines the applicable rules according to the configuration and intended purpose of the product. Identifying the correct configuration from the outset avoids building a regulatory file in the wrong direction.
The two configurations
Configuration 1 — The medicinal product is the principal element.
A medicinal product and a device intended to administer it form a single integral product, intended exclusively for use in that combination and not reusable: pre-filled syringe, disposable pre-filled pen. In this case, the whole falls under Directive 2001/83/EC or Regulation (EC) No 726/2004 (Article 1(9) of the MDR); a reusable injection pen, by contrast, remains a medical device under the MDR. The device part must meet the GSPR of Annex I of the MDR, and the marketing authorisation dossier includes the declaration of conformity, the certificate or the opinion of a notified body on that part (Article 117). The authorisation is granted by the European Commission on the EMA’s opinion under the centralised procedure, or by the national authority (ANSM in France) under the national procedure.
Configuration 2 — The medical device is the principal element.
A medical device incorporates a medicinal substance that acts in an ancillary manner on the body, supplementing the action of the device. Example: an orthopaedic implant impregnated with an antibiotic to prevent post-operative infections, a dressing containing an active antiseptic. In this case, the whole falls under the MDR. The device follows the normal MDR certification procedure, but with an additional step.
The consultation procedure for configuration 2
For devices incorporating an ancillary medicinal substance, the notified body consults a medicinal products competent authority designated by a Member State or the EMA on the quality, safety and usefulness of the substance. Consulting the EMA is mandatory for substances falling exclusively within the scope of the Annex to Regulation (EC) No 726/2004 and for human blood or plasma derivatives (Annex IX, section 5.2).
This consultation is mandatory before the certificate is issued. It adds time and complexity to the certification process: the consulted authority has a defined period to issue its opinion, and that opinion may include requests for additional studies on the substance.
What makes these files complex
The main complexity is the coordination between two regulatory systems with different authorities, data requirements and evaluation logics. The technical documentation must demonstrate conformity with the GSPR of the device and document the quality, safety and clinical usefulness of the substance according to pharmaceutical standards. Both parts of the file must be consistent with each other.
Regulatory source: Article 1(8) and (9) of Regulation (EU) 2017/745 — EUR-Lex