Regulatory Requirements and Guidelines on the Application of CE Marking

The Medical Devices Directive (MDD) 1 and the obligation to affix the CE marking apply to medical devices and medical accessories. According to Article 1 of the MDD

• A medical device refers to any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
• Diagnosis, prevention, monitoring, treatment or alleviation of disease;
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
• Investigation, replacement or modification of the anatomy or of a physiological process;
• Control of conception; and,
• Which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
• An accessory is an article which, whilst not being a device, is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.