On January 21, 2026, Swissmedic announced new requirements for the authorization of medicinal products with integral medical device components, also known as integral combination products.
Requirements regarding a Notified Body Opinion
The new requirements introduce a mandatory Notified Body Opinion for certain integral combination products. This means that manufacturers of these products will need to obtain an opinion from a Notified Body on the conformity of the device part with the relevant Union legislation.
Notified Body Opinion
The Notified Body Opinion is a critical component of the authorization process for integral combination products. It ensures that the device part of the product meets the essential requirements of the relevant Union legislation, such as the Medical Device Regulation (MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Who is affected?
The new requirements affect manufacturers of integral combination products that contain a device part which is subject to the MDR or IVDR. This includes products such as drug-device combinations, where the device part is essential for the delivery of the medicinal product.
What changed?
Prior to the introduction of the new requirements, the authorization process for integral combination products did not always involve a Notified Body Opinion. However, with the increasing complexity of these products, Swissmedic has deemed it necessary to introduce this additional step to ensure the safety and efficacy of these products.
FAQ
- What is an integral combination product?
An integral combination product is a product that contains a medicinal product and a device part, where the device part is essential for the delivery of the medicinal product. - What is a Notified Body Opinion?
A Notified Body Opinion is an opinion from a Notified Body on the conformity of the device part with the relevant Union legislation. - Who is responsible for obtaining the Notified Body Opinion?
The manufacturer of the integral combination product is responsible for obtaining the Notified Body Opinion.
Conclusion
The introduction of the new requirements for integral combination products by Swissmedic is a significant development in the regulatory landscape for these products. Manufacturers of these products must ensure that they comply with the new requirements, including obtaining a Notified Body Opinion, to ensure the safety and efficacy of their products.
Disclaimer
This article is for informational purposes only and is not intended to be a substitute for professional advice. Manufacturers of integral combination products should consult the relevant regulatory authorities and seek professional advice to ensure compliance with the new requirements.
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/kombinationsprodukte/informationen/zl-gesuch-am-mit-integraler-medizinproduktkomponente.html