|Theme||UDI – Combination products|
|Products Concerned||Combination products :
– devices incorporating, as an integral part, a substance which, used separately, would be considered a drug
– devices intended for the administration of a drug
– devices incorporating as an integral part non-viable human tissues or cells or their derivatives
|Regulatory reference||MDR (EU) 2017/745
Article 1(8), 1(9), 1(10)
|Documents mentioned||Directive 2001/83/EC
Regulation (EC) No 726/2004
This document clarifies the application of the UDI to the MD portion of combination products referred to in items 8, 9 and 10 of Article 1 of the MDR :
- devices incorporating, as an integral part, a substance that, when used separately, would be considered a drug
- devices intended for the administration of a drug
- devices incorporating as an integral part non-viable tissues or cells of human origin or their derivatives
If these devices are governed by the MD Regulations, the provisions relating to the UDI must be applied to the part that constitutes the MD.
On the other hand, the MD portion of a combination product that is not governed by the MD Regulation is not required to comply with the UDI requirements.
This document also provides numerous examples to illustrate these two situations.