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 (ref Regulation of 15 December 2005 no 1690 medical devices §1-5 d).
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 (ref Regulations of 15 December 2005 no 1690 medical devices §1-5 c).
There are no specific legislation/regulations or guidelines that govern advertising of medical devices in Norway. It is allowed to advertise for medical devices in Norway. Devices CE- marked, fulfilling the requirements in the applicable directive, can be marketed and sold in Norway.
One of the requirements is that 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.
Otherwise we refer to the general marketing legislation (Marketing Control Act)(lovdata.no) managed by The Consumer Ombudsman and the Market Council (forbrukerombudet.no).
Authorised representative means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under Regulation of 15 December 2005 no 1690 on medical devices.
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.
CE is a product label that means Communauté Européenne. The CE marking is a declaration by the manufacturer that the product complies with the requirements of the relevant Directive, and that the product facilitate a free access in the EEA market. The CE mark does not say anything about the quality aspects of the product in question. Medical devices are one of the product categories that are CE marked. More detailed information under Placing on the market of medical devices.
Clinical Evaluation involves an assessment of the clinical data for the medical device made by the manufacturer and/or notified body (depending on risk class).
The Confirmation given, that a device under normal operating conditions fulfills the requirements for characteristics and performance referred to in the Regulation on medical devices, in addition to an assessment of adverse effects, and whether the risk-benefit ratio specified in this regulation is acceptable, shall as a rule be based on clinical data.
Clinical evaluation is based on
a. Either a critical assessment of relevant and available scientific literature on the safety, performance, characteristics of design and intended purpose, if
- it can be demonstrated that the device corresponds to the device that the information relates to, and
- the data can adequately demonstrate conformity with the applicable requirements
b. Or a critical assessment of all clinical evaluations that is done
c. Or a critical evaluation of the combined data in a. and b.
Clinical Evaluation: «The assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device when used as intended by the manufacturer» MEDDEV 2.7.1 Rev.4 Clinical Evaluation: A guide for manufacturers and notified bodies (ec.europa.eu).
More detailed information under Clinical investigation.
There is no specific procedure for compassionate use of medical devices in Norway (see Conformity assessment exeption).
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.
Conformity assessment exeption
Norway do follow the exemption rule on the Conformity assessment procedures as defined in Council Directive 93/42/EEC Article 11, Point (13):
"By derogation from paragraphs 1 to 6, the competent authorities may authorize, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 to 6 have not been carried out and the use of which is in the interest of protection of health. "
The exemption rule is implemented through the Norwegian Regulations of 15 December 2005 no 1690 on medical Devices, §2-3 Conformity assessment.
The Norwegian exemption rule is not used very often, and is interpreted strictly. The manufacturer may send in an application containing the following information:
- Name of manufacturer and details to specify the device
- Justification on grounds of the protection of health. Is safe and correct use secured?
- Justification of specific need to a targeted patient or group
- Are there any equivalent devices on the market?
- A confirmation from the user/clinician regarding the specific need
- Produced specifically in accordance with duly qualified medical practitioner's written prescription
- Device is given specific design characteristics
- Intended for the sole use of a particular patient.
- Shall not bear the CE-marking
- Manufacturer of custom-made devices shall issue a statement before the device is marketed and put into use.
- A copy of the statement shall accompany all custom-made devices in risk class IIa, IIb and III (for medical devices ref. directive 93/42/EEC).
- This declaration must be available for the individual patient.
The declaration must contain the following information: the name and adress of the manufacturer
- data allowing identification of the device in question
- a statement that the device is intended for exclusive use by a particular patient , together with the name of the patient
- the name of the medical practitioner or other authorized person who made out the prescription and , where applicable, the name of the clinic concerned.
- the specific characteristics of the product as indicated by the prescription
- a statement that the device conforms to the essential requirements in Regulation on medical devices annex ØMU I or annex AIMU VI , and where applicable , indicating which essential requirements have not been fully met, together with the grounds.
- Both the declaration and the written order from a qualified medical practitioner (eg. the written order from the dentist the dental technician) shall be kept for at least five years. For implantable devices the documentation shall be kept for at least 15 years.
Custom-made device is regulated in Regulation of 15 December 2005 no 1690 on medical devices § 5-1a) and § 5-7 for other medical devices and § 4-1a) and § 4-6 for active implantable medical 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. More detailed information under Placing on the market of medical devices.
Dental bleaching agents
Dental bleaching agents do not meet the definition for medical device of the Directive 93/42/EEC.
CE-marked disinfectants are classified as medical devices as they are considered as required accessories to medical devices.
For further information see Disinfectants under Laws and regulations.
There is no specific Norwegian regulatory framework for the handing out of free samples of medical devices. The basic requirements for free samples are similar to those for other medical devices. Medical devices that are CE- marked, fulfilling the requirements in the applicable directive, may be marketed freely within the EU / EEA. Labeling and instruction for use for free samples must be in Norwegian, corresponding to other medical devices.
Other information relevant to know when handing out free samples of medical devices:
Global Medical Device Nomenclature is a system of internationally agreed terms used to identify medical devices.
Instruction for use
A medical device must be provided with, or have attached information necessary for the safe and proper use of the device. The information provided should take into account the training and knowledge of the potential user (ref. Regulation of 15 December 2005 no 1690 medical devices § 2-5). A more detailed description of what instructions for use shall contain are described the Annexes AIMU I, section 15, IVDMU I section 8.7 and ØMU I section 13.6.
Instructions for use in electronic form
Means instructions for use
- displayed in electronic form by the device
- available on an portable electronic storage medium that is supplied with the device
- available via a website
Prior to initiating a clinical investigation of a medical device a confirmation that the patients are insured by a private insurance company or by Norsk Pasientskadeerstatning (NPE, compensation claims from patients) must be submitted. Normally, patients in clinical investigations are covered by NPE, but a confirmation from NPE that subjects in the present study are insured, must be submitted. If the NPE does not cover the patients in the study a certificate of insurance from a private insurance company, must be submitted.
In vitro diagnostic medical device
In vitro diagnostic medical device means any medical device which intended to be used in vitro for the examination of specimens derived from the human body for the purpose of providing information. Further definition in Regulations of 15 December 2005 no 1690 medical devices § 1-5b.
As a main rule; information referred to in the following annexes in the Norwegian regulation of 15. December 2005 no. 1690 on medical devices § 2-6 must be in Norwegian:
Annex AIMU I no. 13, 14, and 15 (for active implantable medical devices)
Annex IVDMU I part B no. 8, (for in vitro diagnostic medical devices)
Annex ØMU I no. 13 (for medical devices)
Information in Norwegian is given as label and instructions for use. For further details see Language requirements (PDF).
If a Field Safety Notice is containing information refered to in these annexes the Field Safety Notice should be written in Norwegian language.
Medical device means any device intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, compensation for an injury or handicap.
In addition some devices for control of conception, and devices for disabled fall under the definition.
Medical devices are further defined in Regulation of 15 December 2005 no 1690 on medical devices § 1-5a. Some medical devices can be in the borderline of other product areas. The most common are:
- personal protective equipment
- products for advanced therapy
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, the term "animal tissue" is 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 EU Authorized Representatives have to register with information regarding registered address of business and description of the medical device concerned (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 Norwegian regulation of 15 December 2005 no 1690 on medical devices only regulates medical devices to be used for human beings.
Use of electromedical devices on animals for diagnostic or therapeutic purposes is regulated in Regulation of 29 November 2013 on use of Medical devices. For further details, contact Norwegian Directorate for Civil Protection (DSB) as competent authority for electrical products.