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 incorporates an accessory medical device for its administration: pre-filled syringe, injection pen, transdermal device. In this case, the whole falls under the medicinal products Directive 2001/83/EC. However, the safety and performance requirements of the medical device component are assessed against the GSPR of Annex I of the MDR. The competent authority for the marketing authorisation is the EMA or ANSM, depending on the applicable 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 must consult either the EMA (for substances falling under the centralised procedure) or the national competent authority for medicinal products, on the quality, safety and clinical usefulness of the substance.
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