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The FDA guidance documents do not establish legally enforceable re-
sponsibilities, but rather describe the Agency’s current thinking and prac-
tices and should be viewed only as recommendations.

9.3 EU submission process
9.3.1 Regulatory classification

There is not a specific category of combination products in EU regulations;
products are categorized as either medicinal products or medical devices
depending on their principle mode of action. Products that combine a me-
dicinal product or substance and a medical device are regulated under the
Medical Devices Directive (Directive 93/42/EEC), the Medical Devices
Regulation (Regulation EU 2017/745), or the Directive for medicinal
products (Directive 2001/83/EC). Essentially, if the principle mode of ac-
tion is physical, for example, a drug-coated stent, this would be classified as
a device but if the principle mode of action is pharmacological or immu-
nological, for example, a syringe pre-filled with a biopharmaceutical for
administration, it would be classified as a medicinal product. The legislative
acts for devices and medicinal products are intended to ensure appropriate
interaction involving combination products in consultations during premar-
ket assessment and of exchange of information from postmarket oversight.
It is important to be aware that the Medical Devices Directive, which
was implemented in 1993, is in transition to be replaced by the Medical
Devices Regulation. The Medical Devices Regulation came into force in
May 2017 with a 3-year transition period until application in May 2020. In
particular, the Medical Devices Regulation amends the Directive on me-
dicinal products in relation to applications for marketing authorization of
medicinal products that integrate a medical device element.
Any device that is intended to administer a medicinal product is gov-
erned by the Medical Devices Regulation unless it takes the form of a
single integral product. Such an integrated product would be intended
to administer a medicinal product exclusively in the given combination
and would not be reusable. Such an integral product is governed by the
Directive on medicinal products or Regulation (EC) No 726/2004, which
established the EMA, as applicable. When an integral device is covered by a
marketing authorization for a medicinal product, the relevant general safety
and performance requirements set out in the Medical Devices Regulation
apply as far as the safety and performance of the device part of the single