For a product to be regulated as a medical device in the EU, it must meet the definition as defined within the EU Medical Device Regulation 2017/745 (MDR). If the product does qualify as a medical device, it must then meet all the requirements set forth in the MDR.
The EU MDR defines a medical device as follows:
‘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:
- 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,
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.
The following products shall also be deemed to be medical devices:
- devices for the control or support of conception;
Article 2(1), EU MDR
- 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.
Therefore, any product which meets the above definition will be considered to be a medical device in the EU.
Qualification as a Medical Device #
The first step in determining whether or not a product is a medical device is to clearly define its intended purpose and mode of operation. The intended purpose should answer:
- What is the device intended to be used for?
- What are the indications of the device?
- What are the marketed claims?
- How does the device meet its intended purpose?
Equipped with a clear device description, consult the definition in Article 2(1) of the MDR. Based on this, you may decide whether your product qualifies as a medical device, or not. It is recommended that this justification is recorded within your technical documentation (e.g. the Device Description and Specification document).
Borderline Devices #
There exist some products which are considered to be “borderline” devices. These are products which, due to their intended purpose and mode of action, are difficult to specifically determine the legislation which they must follow (e.g. medicinal products, biocides, PPE).
A careful determination of the device’s intended use should avoid this situation, however, we have come across a few tricky devices in the past. One may also consult the Borderline Manual which may provide some help in determining where your product falls into.
For those devices incorporating medicinal substances, it will be helpful to consult MDCG Guidance 2022-5 which provides plenty of detail into identifying which legislation and which requirements must be met by the device prior to placing on the EU market.
Additional Considerations #
In some case, the product may not so clearly be captured by the definition of a medical device. There are additional considerations to keep in mind:
- Is the product an accessory to a medical device?
- Is the product a system or procedure pack?
- Does the product fall under Article 22?
- Does the product fall under Annex XVI?
Each one of the above comes with its own additional regulatory considerations and requirements.
What Comes Next? #
Once the product has been successfully qualified as a medical device, the next step will be to determine its classification in accordance with the Rules of Annex VIII and then determine the appropriate conformity assessment procedure, as defined in Article 52. See more information on the classification system, here.
If you are having trouble qualifying your product, we can help build a medical device Qualification and Classification Rationale document that can be used as part of your technical documentation. You can find more information about this service, here. Otherwise, get in touch to learn how we can help your company meet its regulatory goals.