Active implantable medical device
Active implantable medical device means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.
Active medical device
Active medical device means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.
There are no specific legislation/regulations or guidelines that govern advertising of medical devices in Norway. Advertisement for medical devices in Norway is legal. CE marked medical devices may be marketed and sold in Norway.
The performance of the medical device shall be equivalent to those specified by the manufacturer. Allegations of a particular effect on the disease, disorder or other performance must be documented by the manufacturer. The Norwegian Medicines Agency may intervene against CE marked medical devices that do not have the alleged medical effect.
We refer to the general marketing legislation (Marketing Control Act).
Authorised representative means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under MDR og IVDR.
Breast Implants - PIP - Poly Implant Prothèse
The Norwegian Medicines Agency maintains the recommendation that women with PIP breast implants should contact their clinic if they have suspicion of the implants leaking. Individual assessment must still be made, and women who are concerned are recommended to contact their physician for consultation and assessment of the need for further investigation.
There is no medical, toxicological or other data that provide any reason for recommending the removal of PIP breast implants. Report from Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR): Preliminary Opinion on the safety of Poly Implant Prothèse (PIP) Silicone Breast Implants (2013 update) September 2013.
Communauté Européenne (CE) is a declaration by the manufacturer that the product is compliant with the legal requirements, and that the product may be sold on the EU/EEA market. The CE mark does not say anything about the quality of the product in question. Medical devices are one of the product categories that are CE marked. For more information, see placing on the market of medical devices.
Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
There is no specific procedure for compassionate use of medical devices in Norway. We refer to the derogation from the confomirty assessment procedure under MDR article 59 and IVDR article 54.
A conformity assessment is an assessment of a medical device where the purpose is that the manufacturer shall document that the product meets the provisions applicable for the product in the regulation. More detailed information under Placing on the market of medical devices.
Custom-made device means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;
Declaration of conformity
The EC declaration of conformity is the manufacturer or authorised representative's documentation for that the medical device can be placed on the market in EU. The manufacturer ensures and declares that the product meets the provisions applicable for the product in the regulation. For more information, please see placing on the market of medical devices.
Some disinfectants are classified as medical devices.
The basic requirements for free samples are similar to those for other medical devices. Medical devices that are CE marked may be marketed freely within the EU/EEA. Labelling and instruction for use for free samples must be in Norwegian language.
Global Medical Device Nomenclature is a system of internationally agreed terms used to identify medical devices.
In vitro diagnostic medical device
In vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
- concerning a physiological or pathological process or state;
- concerning congenital physical or mental impairments;
- concerning the predisposition to a medical condition or a disease;
- to determine the safety and compatibility with potential recipients;
- to predict treatment response or reactions;
- to define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices
Medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in MDR Article 1(4) and of those referred to in the first paragraph of this point.
Non-viable animal tissue
Animal tissues as well as products derived from this, in which infectious agent's ability to cause infections or pathogenic reactions are removed. In the Regulation on Medical Devices, animal tissue means tissue that originates from bovine, ovine and caprine species, deer, elk, mink and cats.
Own Brand Labeller
An own (private) brand labeller (OBL) purchases a finished (or component parts of a) medical device from the Original Equipment Manufacturer (OEM), which he then places on the market under his own name or trade mark (brand label). It appears that this economic operator, the own brand labeller, meets the definition of manufacturer as set out in the medical devices Directives.
For more information see EU's interpretative document (ec.europa.eu, PDF).
Only Norwegian manufacturers or Norwegian Authorised Representatives have to register. For more information, please see registration of medical devices.
Technical documentation is a written documentation of safety and the manufacturer's intended use of a medical device. The document must contain information of product construction, manufacturing, testing, risk analysis and clinical evaluations. The purpose of the documentation is that the manufacturer shall document that the product meets the provisions applicable for the product in the regulation. More detailed information under Placing on the market of medical devices.
The EU regulations on medical devices only apply for medical devices to be used for human beings.
Use of electromedical devices on animals for diagnostic or therapeutic purposes is regulated in Regulation 29 November 2013 on the Use of Medical devices. For further details, contact Norwegian Directorate for Civil Protection (DSB) as competent authority for electrical products.