Journal of Diagnostic Techniques and Biomedical Analysis publish the articles related to medical devices. A medical device is any device intended to be used for medical purposes. Thus what differentiates a medical device from an everyday device is its intended use. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.

Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease,
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
• investigation, replacement, modification, or support of the anatomy or of a physiological process,
• Supporting or sustaining life,
• Control of conception,
• Disinfection of medical devices
• Providing information by means of in vitro examination of specimens derived from the human body;  and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.

CE marking to certify safety and performance

Medical devices must be CE marked before they can be placed on the market. CE marking shows that the device complies with EU legislation. If a medical device is in a higher risk class than class I, then a so-called notified body must assess if the device can be CE marked. A notified body is a private organisation which has been authorised to assess the documentation submitted by the company intending to sell the product. The notified body assesses if the documentation for the product's safety and performance is sufficient for the product to be CE marked.

The role of the Danish Medicines Agency is to conduct oversight of the notified bodies and to react if it becomes aware of safety problems involving specific types of medical devices. As part of this oversight, we respond to relevant medical device incident reports submitted to us by companies, healthcare professionals or citizens.

Katherine Gray
Editorial Coordinator
Journal of Diagnostic Techniques and Biomedical Analysis
SciTechnol Journals
diagnostics@scitecjournals.com