What is medical device?
There are different definitions of a medical device.
FDA defines medical device as follows:
A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
According to Medical Device Directive (MDD, 93/42/EEC) of European Union:
‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the 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;
Which product certifications are mandatory?
In countries applying CE marking regulations and Medical Device Directive (MDD, 93/42/EEC) product testing and certifications of medical devices are mandatory. There are harmonised test standards under MDD and appropriate ones shall be applied to the medical device. Electromagnetic Compatibility (EMC), Safety testing and inspections are required according to test standards.
In USA, FDA approvals are mandatory. There are different classifications of medical devices:
Medical devices are classified based on the risks associated with the use of the device. Devices are classified as Class I, Class II, or Class III, with Class I being the lowest risk and Class III the highest risk.
- Class I – These are devices that present minimal potential for harm to the user. Examples include enema kits and elastic bandages. 35% of medical device types are Class I and and 93% of these are exempt from pre-market review.
- Class II –These are devices that generally present a moderate risk of harm to the user. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 53% of device types are Class II, most of which require FDA review through premarket notification (510(k)).
- Class III – These are devices that sustain or support life, are implanted, or present potential high risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 9% of device types are Class III and require FDA review through premarket approval (PMA) or humanitarian device exemption (HDE).
- Unclassified/Not classified – These are device types that FDA has not yet classified. 3% of device types are unclassified/not classified..
In Australia, TGA, which is an official authority of Australia, is regulatory body for medical devices. In order to market medical devices in Australia, TGA approvals are mandatory. Most of the tests shall be applied to medical devices are similar to CE marking testing standards since the standards are based on international standard organizations like IEC, ISO…
In Brazil, official authority is ANVISA. In order to get ANVISA product marking on medical devices, some documentation and official application are necessary.
You can contact Ege Test Center for product certifications of Medical Devices. Here is our Online Application Form. You can also send us e-mail or call us, we will fill your product testing and certification needs.