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NorTrials Medical Devices
The NorTrials centre for medical devices is located at St. Olavs hospital, Trondheim University Hospital.
Introduction
Medical devices is central to most diagnostics and treatment of patients in hospitals. Clinical studies in research, development and testing of medical devices (technology) is something that most hospitals engage in to a greater or lesser extent, either in their own research, collaborative projects with universities and research institutes, or in collaboration with industry.
Organization
St. Olavs hospital (Trondheim University Hospital) has extensive experience in research, development, innovation and testing of medical devices and technology, also in collaboration with industry.
The NorTrials centre for medical devices belongs to the Centre for innovation, medical devices and technology, a unit in the Clinic for e-health and innovation at St. Olavs hospital. The previous name of the centre and the research infrastructure was "The Operation Room of the Future". We have projects, infrastructure, national roles, etc. in collaboration with the other health regions, e.g. NorMIT infrastructure in collaboration with Oslo University Hospital (the Intervention Centre). In addition, we have close collaboration with universities and SINTEF in research and development of medical technology.
NorTrials Medical Devices will lift this collaboration further and contribute to coordination and increased participation from several hospitals, small and large around the country, in studies involving medical devices in collaboration with national and international industry. We have established a network of testbeds within the hospitals for units that are specially rigged for studies that include medical devices.
NorTrials Medical Devices has employees with expertise covering the whole process from idea to market for medical devices, and especially in clinical piloting, financing of collaborations for development and testing, and expertise in regulatory matters, e.g. in connection with the Medical Device Regulation (MDR).
Medical devices to be used for patient treatment in Norway must be CE-marked in accordance with the new EU regulations for medical equipment:
Regulation (EU) No. 2017/745 on medical devices (MDR) entered into force on 26 May 2021.
Regulation (EU) No. 2017/746 on in vitro diagnostic medical devices (IVDR) entered into force on 26 May 2022.
It is the intended purpose of the equipment that determines whether the equipment is covered by these regulations, and thus must be CE marked as a medical device. The definition for medical devices is given in MDR article 2 (1), and the definition for in vitro diagnostic medical devices is given in IVDR article 2 (2).
In order to CE mark a medical device, good clinical documentation is required that the device complies with the requirements for safety and performance given in the regulations. Clinical trials or performance studies can be carried out to collect enough clinical data about the equipment to be able to evaluate whether the equipment is easy to use and works according to its intended purpose.
Clinical trials of medical devices must be planned and carried out in accordance with MDR article 62. Trials should be carried out in line with good clinical practice described in the international standard ISO 14155:2020 "Clinical investigation of medical devices for human subjects - Good clinical practice". Performance studies of equipment for in vitro diagnostics must meet the requirements of IVDR article 57. Good clinical practice for performance studies is described in ISO 20916:2019 "In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good clinical practice".
In Norway, it is the Directorate for Medical Products (DMP) that validates and assesses applications for clinical trials/performance studies of medical devices/IVD. On the same day that the application is sent to the DMP, an identical application must also be sent to the Regional Committee for Medical and Healthcare Research Ethics at the Committees for Clinical Trials of Medicines and Medical Devices (REK-KULMU) for ethical prior approval.
The bill that was put forward in Ot.prp. no. 74 (2006-2007) built on NOU 2005:1 "Good research — better health", and the aim was to clean up and simplify the regulations for medical and healthcare research. The regulation in this area is now largely consolidated in one act, and researchers must mainly deal with one body when applying for approval of research projects. This body is the Regional Committees for Medical and Healthcare Research Ethics (REK).
REK KULMU is the name of the committee that carries out research ethics assessments for clinical trials of drugs and medical devices. It has a national mandate, but is administratively affiliated with REK South-East. REK KULMU was established in 2020 to meet Norway's obligations to follow up the EU regulations.
Thomas Langø, Sara Edvardsen and Jan Gunnar Skogås
Network
NorTrials Medical Devices has established a national network of testbed facilities in the hospitals and has a large network for testing/development outside the hospitals through collaboration with health clusters and researchers.
We cooperate with HealthCatalyst, among others, to facilitate health technology testing.
