This guidance applies to projects where medical equipment is to be developed. Project leaders should familiarize themselves with information from the Norwegian Medicines Agency [Statens legemiddelverk].
What are medical devices?
Medical devices are defined in the Medical Devices Ordinance as any instrument, device, equipment, software, implant, reagent, material or other object which, according to the manufacturer, is intended to be used, alone or in combination, on humans for the purpose of one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosing, treatment or alleviation of disease
- diagnosis, monitoring, treatment, relief of or compensation for injury or disability
- examination, replacement or alteration of the anatomy or of a physiological or pathological process or condition
- to produce information by means of in vitro examination of sample material from the human body, including organ, blood and tissue donations.
The following products must also be considered medical devices:
- products for pregnancy prevention or fertilization assistance
- products that are particularly intended for cleaning, disinfecting or sterilizing medical equipment.
Initiation of projects relating to the development of medical equipment
The development of medical equipment does not in itself require any official authorisation. If health information is to be used in the development and there is no consent from the individual, an exemption from the obligation of confidentiality must be applied for (see "product development" [«produktutvikling»] under [ clarify purpose]).
Strategic assessments at start-up
At the start of projects that aim to develop medical equipment, it should be considered whether the equipment is to undergo a conformity assessment and CE marking, or whether the equipment is to be put into use on the basis of the exception for in-house production (see below). This decision is important, because the process of conformity assessment and CE marking has specific requirements for how to document the equipment's safety and performance.
CE marking is a mark that is applied to the equipment to signal that the equipment has been assessed and shown to pass the conformity requirement. CE marking is a prerequisite for putting into use and/or marketing medical equipment.
The main rule on conformity assessment and CE marking
Medical equipment must meet a number of safety and performance requirements in the Medical Devices Regulation (MDR), before the equipment can be put into commercial use or placed on the market. The main rule is that manufacturers of medical equipment must demonstrate that the requirements of the MDR have been met through a so-called "compliance assessment". The scope of the conformity assessment depends on which risk class the equipment falls under. There are extensive requirements for documentation and for the manufacturer's systems for risk management and monitoring of the equipment's safety and performance.
The advantage of CE marking is that the equipment can be used by several healthcare institutions. CE marking enables the commercialization and sale of the equipment on the market.
Exemption for in-house production
In-house manufacturing means developing medical equipment only for use within one's own healthcare organisation. When specific conditions are met, in-house developed equipment can be used without CE marking. Whoever develops and uses such equipment is nevertheless responsible for ensuring that the general safety and performance requirements in the MDR are met.
Reasons for choosing in-house production may be that the process of conformity assessment is extensive and requires a lot of time and resources. However, there are a number of conditions that must be met for self-production to be acceptable. If one chooses in-house production, there are restrictions on who can use the product/equipment. Without CE marking, equipment developed at one healthcare facility cannot be used at another healthcare facility. This applies even if the other health organization is under the same regional health authority [regionale helseforetak] (RHF).
In order to make an exception from the requirement for conformity assessment, the following conditions must be met (MDR art. 5 no. 5):
- The equipment is not transferred to another legal entity
- The production and use of the equipment takes place within the framework of suitable quality management systems.
- The health institution justifies in its documentation that the special needs of the patient target group cannot be met, or cannot be met with a suitable level of performance, using equivalent equipment available on the market.
- On request, the health institution provides information to the competent authority about the use of such equipment, which must contain a justification for the production, modification and use of the equipment.
- The health institution prepares a declaration which it must make publicly available (more detailed requirements for the declaration appear in the MDR)
- The health institution prepares documentation that makes it possible to gain an understanding of the manufacturing facility, the manufacturing process as well as data on the equipment's design and performance, including the intended purpose, which is sufficiently detailed for the competent authority to determine that the general requirements for safety and performance laid down in the MDR Annex 1 is fulfilled.
- The health institution takes all necessary measures to ensure that all equipment is produced in accordance with the documentation referred to in letter f)
- The health institution reviews the experiences from the clinical use of the equipment and takes all necessary corrective measures.
Clinical testing of medical devices
By "clinical trial" is meant a systematic trial that includes one or more test participants and which is carried out to assess the safety or performance of a device. Testing algorithms on retrospective data, for example, will not be considered clinical trials.
It is in the nature of clinical trials that a product/tool must be developed in order for this to be "tested". In practice, it is conceivable that testing takes place at various stages of development and as part of the development process.
- Clinical testing of medical equipment must be approved in advance by REK.
- It must be assessed whether clinical trials must also be pre-approved by or reported to the Norwegian Medicines Agency (SLV) (guidance). The main rule is that a clinical trial must be pre-approved by SLV. Exceptions apply to equipment that has already been assessed for conformity and that is tested within the framework of the conformity assessment.