What type of products can be classified as medical devices?
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 control of conception products, as well as tools for the handicapped people are also considered as medical devices.
An in vitro diagnostic (IVD) medical device is a device intended for the analysis of samples from the human body for medical purposes.
Medical devices are defined in the Act 12 January 1995 nr. 6 on medical devices § 3 and Regulation of 15 December 2005 no 1690 on medical Devices § 1-5 (lovdata.no).
Some medical devices may also lie in the interface with other product areas. The most common are: drugs, cosmetics, biocides, machinery, personal protective equipment, products for advanced therapy.
The intended use for and scope of the product, as well as the main mechanism of action of the product, is essential when evaluating which regulations the product apply to.
See also Guidance document for Borderline products.
Classification of medical devices
Medical devices (other) are divided into the following risk classes (ref. Regulation of 15 December 2005 no 1690 on medical devices Annex ØMU IX Criteria for classification (lovdata.no)):
- Class I (with special requirements if the device is sterile (Is) or have a measuring function (Im))
- Class IIa
- Class IIb
- Class III
The classification reflects
- risks associated with use
- the vulnerability of the part of body the device are used on
- duration of us
The highest class (III), include devices that come into contact with the central nervous system, the heart and the central circulation as well as medical devices with drugs incorporated.
Further information is found in MEDDEV 2.4/ Guidelines for classification of medical devices.
For active implantable medical devices (AIMU) there is generally a high risk of use and this group is not divided into risk categories.
In vitro diagnostic (IVD) medical device (IVDMU) is divided into the following categories (ref. Regulations of 15 December 2005 no 1690 on medical devices Annex IVDMU II List A and B (lovdata.no)):
- List A
- List B
- Self-testing IVD
National authorities and other competent authorities in the EU collaborate on classification decisions. In cases where the classification of a product as a medical device is not obvious, or when there is doubt about the risk classification, the European authorities discuss the case among themselves. Overview of decisions is found in Manual on borderline and classification in the community regulatory framework for medical devices which is continuously updated.