Why it is important
It can make a world of difference if you know what the definition of a medical device is – and is not. This is true both if you are selling a product that you don’t think is a medical device when it in fact is, and the other way around. This may also be true if you plan to sell a product that is a medical device, that you think is a medicinal product or drug, or vice versa.
If you are selling a medical device in the EU or US, you are required to fulfil certain regulatory requirements. Not to do so is a criminal act; thus it really makes sense to get your product correctly classified. Furthermore, the advantage of ending up with a medical device as opposed to a drug is that the cost and time required to gain market access is in most cases significantly less for a medical device compared to that of a medicinal product.
In layman’s terms, a medical device is something that is used for surgery, therapy, or diagnosis. In the EU, some contraceptives are also considered as medical devices, as well as stand-alone software.
Medical device definition EU
The more formal definition in EU of a medical device can be found in the medical device directive, 93/42/EEC Article 1 §2:
(a) ‘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;
Medical device definition US
In US, the definition comes from Section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act:
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 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.”
There are some products that you may believe to be drugs, but when looking at them in more detail you may discover that they do not achieve their primary purpose by pharmacological, metabolic, or immunological means. This means that the product may not be a medicinal product, but rather a medical device. This is true for some IVF media, tissue and organ preservation solutions, and products using enzymes or bacteria that have an effect on viruses and bacteria but not on the body itself.
If you are in doubt about whether your product is a medical device or not in the EU, you may consult the current versions of the following references:
– Meddev 2.1/3 Borderline products, drug‐delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative
– Manual on borderline and classification in the community regulatory framework for medical devices
– Meddev 2.4/1 Classification of medical devices