Medical gas pipeline systems
The Norwegian Medical Products Agency has assessed whether medical gas pipeline systems (MGPS) can be considered as medical devices.
Based on the definition of medical device in Regulation (EU) 2017/745 (MDR) Article 2 (1), the Norwegian Medical Products Agency has reached the following conclusions:
- MGPS can be considered as medical devices if the intended purpose meets the definition of a medical device.
- The part of a gas system that transports medical gases (medicinal products) can be considered as a medical device.
- Gas panels in patient rooms/treatment rooms and bedside devices are in most cases medical devices.
- The manufacturing of medical gases is considered to fall within the scope of manufacturing of medicinal products.
New Regulation and requirements
The Norwegian Medical Products Agency's previous position was that medical gas pipeline systems in healthcare institutions were part of the organization's infrastructure. Quality assurance and requirements for the handling of medical gases in existing systems will therefore be covered within the framework of the health institution’s quality management system. The Norwegian Medical Products Agency considers it too challenging and expensive to prepare the necessary documentation for the manufacturing of an existing MGPS.
If an existing MGPS, where the intended purpose meets the definition of a medical device, is modified in a way that the changes are considered significant, this will require a new conformity assessment according to the requirements of the MDR. Significant changes may include design modifications that alter the built-in control mechanism, the devices' operating principle, changes to the energy source or the alarm system. Guidance on significant changes can be found here (pdf).
Starting from January 2024, the Norwegian Medical Products Agency (which will then be named the Norwegian Medical Products Agency) will require that all new (planned) MGPS follow the regulations for medical devices if the intended purpose falls within the definition of a medical device. It is expected that the systems are designed following the "state of the art," meaning that relevant guidelines and standards are adhered to.
MGPS for commercial use
If a MGPS is intended for commercial use, meaning that the medical device is to be placed on the market, the manufacturer must conduct a conformity assessment and CE mark the MGPS as a medical device according to MDR. All general obligations for manufacturers set out in MDR Article 10 must be fulfilled. The manufacturer of the CE marked MGPS is responsible for ensuring that the device complies with the regulation. The business/healthcare institution has a responsibility to use the MGPS in accordance with the manufacturer's instructions for use. More information about the requirements for medical devices before they can be placed on the market can be found on this page.
MGPS as a system
MGPS can also be placed on the market as a system and will then be subject to the requirements for system manufacturers in MDR Article 22, cf. Article 2 (11). The system may consist of CE marked medical devices and other products that are legally placed on the market. The system shall not be further CE marked, but shall bear the name and address of the entity that assembled the system. The assembler of the system must verify that the devices and other products are compatible with each other and in accordance with the manufacturers' instructions. It is required that the entity assembling the system prepares a declaration, according to the requirements in MDR Article 22. More information about systems and procedure packs with medical devices can be found on this page.
In-house manufacturing of MGPS
MGPS may also follow the procedures for in-house manufacturing of medical devices outlined in MDR Article 5 (5). More information about the requirements for in-house manufacturing of medical devices can be found on this page (only in Norwegian).