The Norwegian Directorate of Health is the competent authority for medical devices in Norway. This implies that the Directorate has administrative and advisory responsibilities related to legislation and supervisory authority over manufacturers, distributors and notified bodies. As a part of the market surveillance all Norwegian manufacturers of medical devices shall register in the Medical Device Database (Utstyrsregisteret). The responsibility for the medical device vigilance system is added to the Directorate of Health.
A medical device is a device intended by its manufacturer to be used specifically to diagnose, prevent, monitor, treat or alleviate disease, injury or disability in humans. Some birth control products, as well as tools for the handicapped people are also considered as medical devices (for the full English definition see dir 93/42 article 1, 2a).
An in vitro diagnostic (IVD) medical device is a device intended for the analysis of samples from the human body for medical purposes.
A product that achieves primary effect through pharmacological, immunological or metabolic action is not considered as a medical device – this type of product is regulated by Norwegian Medicines Agency (legemiddelverket.no).
Medical devices are defined in the Act of 12 January 1995 no 6 on medical devices § 3 and the Regulations of 15 December 2005 no 1690 on medical Devices § 1-5. The Norwegian Regulations on medical devices implements the three EU directives on medical devices in one text.
Medical devices shall comply with the essential requirements given in the regulations and directives before the device can be CE marked (see also Notified Body), as a confirmation that regulatory requirements are met. The way to CE marking depends on the risk classification of the device.
The regulations on medical devices also require manufacturers to conduct clinical investigations in Norway. Notification of the trial shall be sent to the Directorate of Health (further information under Clinical investigation).
With reference to the EEA Agreement, Norway has the same rights and obligations as other EU Member States with regard to requirements for medical devices. Due to the EU Directives, manufacturers/authorised representatives of medical devices have a responsibility for internal control (risk analysis, conformity assessment procedures). Medical devices that are CE marked in one EU/EEA country can freely be placed on the market in all EU/EEA countries.
The Directorate of Health may upon request issue time-limited Free Sales Certificate for Norwegian manufacturers of medical devices to be exported to countries outside the EU/EEA.
The national system for the introduction of new health technologies (methods) within the specialist health service (nyemetoder.no) is affiliated in the Norwegian Directorate of Health. Assessment of health technologies in relation to the introduction of medical devices, diagnostic methods and procedures is one of the tasks.
The Norwegian legislation
The EU Directives on medical devices are implemented in Act of 12 January 1995 no 6 on medical devices (lovdata.no) and Regulation of 15 December 2005 no 1690 on medical devices (lovdata.no).
Electromedical devices and medical devices generating radiation are regulated through the Act of 24 May 1929 no. 4 on Inspection of electrical installations and electrical devices (lovdata.no) and the Act of 12 May 2000 no. 36 on radiation protection and use of radiation (lovdata.no), which are administered by the Norwegian Directorate for Civil Protection (dsb.no) and the Norwegian Radiation Protection Authority (nrpa.no).
Act on Medical devices
The Act on Medical devices regulates the manufacture, marketing, trade and use of medical devices. The purpose of the Act is to prevent harmful effects, incidents and accidents, and to ensure that medical devices are being evaluated and used in a professional and ethical manner.
Regulation on Medical Devices
The Regulation applies to everyone who manufacture, market and trade medical devices for use in Norway, and Notified bodies.
The aim of the regulation is to ensure that medical devices do not cause harmful effects to patients, users and any other person’s safety in association with manufacturing, construction, trade and use of these devices.
Regulation on use of Medical devices
This regulation applies to the health care services use of medical devices and any use of electromedical device by public and private business. The aim of the regulation is to ensure that medical devices at any given time are safe, are correctly maintained and are used correctly in accordance with its intended purpose.
The EU directives and guidelines
EU's three principal Directives regarding Medical devices are:
In addition, EU has adopted amendment directives and implementing regulations. An overview of EU's regulatory framework is to be found on the European Commission website.
To obtain a common understanding of the regulatory requirements, it is at the European level developed a number of guidelines (MEDDEVs). The lists of guidelines are to be found on the European Commission website.
The European Commission published the 26th September 2012 proposals for new regulations for medical devices and in vitro diagnostic medical devices.
The proposals are being processed in the Council and Parliament. An overview of documents related to the revision can be found on the European Commission's website.