As a manufacturer, it is vital to know whether your device is a medical device within the scope of the MDR as this would determine if the MDR applies to your device or not. You might think that a medical device is any product that is found in a hospital that is not a drug, however it’s not that simple.
The definition of a medical device can be found as the very first definition within Article 2 of the EU 2017/745 MDR;
We can agree that the definition from the MDR is a mouthful, and it would be better to split up the definition into distinct parts and explain each part.
Extract from the MDR (Segment 1)
‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
Clarification (Segment 1)
Basically, from the first part we can gather that this is a product that is meant to be used on humans and has a clear medical purpose.
Extract from the MDR (Segment 2)
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
Clarification (Segment 2)
From this second part above we can say that the device diagnosis, monitors and treats disease and disability, modifies anatomy, and provides information by means of in vitro examination of specimens.
Extract from the MDR (Segment 3)
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
Clarification (Segment 3)
Basically, the above states that the device should not be a drug.
Extract from the MDR (Segment 4)
The following products shall also be deemed to be medical devices:
— devices for the control or support of conception;
— products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
Clarification (Segment 4)
Lastly, we have the paragraph above stating that a medical device could be a contraceptive, devices that are used for the cleaning and sterilization of devices and the devices listed in Annex XVI which are a list of 6 products without a clear intended medical purpose. These are the following products;
- Contact lenses or other items intended to be introduced into or onto the eye
- Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts.
- Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection
- Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
- High intensity electromagnetic radiation emitting equipment intended for use on the human body for skin resurfacing, tattoo or hair removal or other skin treatment.
- Equipment intended for brain stimulation.
Examples
Often times, it is easy to fit the definition with a product, however sometimes a product could fall into a grey area. Some examples of medical devices are shown below;
- Wheelchair: This device has a clear medical intended purpose as it alleviates the patient from injury/disability
- Cardiac Pacemaker: This device has a clear medical intended purpose as it is alleviating patients from a cardiovascular condition of Tachycardia/Bradycardia.
- Step Tracking Application on your Smartphone: This device does not have a clear medical intended purpose and is not considered a medical device as it is being used to monitor your steps.
Final Remarks
Once you have determined that your device is a medical device, then you would need to classify your medical device in accordance with the classification rules laid out in Annex VIII Chapter III of the MDR. The MDR is a legislation that takes a risk-based approach, taking the above examples, we can agree that a wheelchair will not be as heavily regulated as a pacemaker as they have different risk classifications. The classification rules will help you classify the risk of your device and hence the conformity assessment route that needs to be taken in order to comply with the MDR for CE certification. The risk varies from low-risk device classified as a Class I to high-risk device classified as a Class III.
It is important for manufacturers to understand the definition of a medical device and classify it in accordance to these regulations before they start any processes to place them on the market. Advena Ltd can help you with classifications of your medical devices as well as other consultancy services to help get your product ready for the EU market.
