Medical device rationale

The decision on whether or not the regulation applies to the product under consideration is a fundamental decision. Fortunately, in most cases the decision is relatively straightforward.

The decision primarily depends on whether or not the product under consideration fulfils the definition of a “medical device” given in Article 2 (1). However, given that the deciding factors are primarily determined by the intended medical use, independent of product features and specifications, it is recommended to first define the intended purpose of the product (see separate page), before describing the rationale for the product under consideration being a medical device.

Question 1: Is the product under consideration intended to be used for human beings?

Answer: If the answer to question 1 is yes, the product could be a medical device, continue to ask the next question. If the answer to question 1 is no, if the product is not intended to be used for human beings, the product is not a medical device and the regulation is not applicable.

Question 2: Is the product under consideration intended to be used for one of the specific medical purposes listed below?

— 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?

Answer: If the answer to question 2 is yes, as well as to question 1, the product could be a medical device, continue to ask the next question. If the answer to question 2 is no, if the product is not intended to be used for human beings, the product is not a medical device and the regulation is not applicable.

Question 3: Does the product under consideration 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? (Important: note the negative question)

Answer: If the answer to question 3 is yes, as well as to questions 1 and 2, the product fulfils the definition of a medical device and the regulation likely applies. For the majority of products the three questions above will normally be sufficient to determine whether or not the regulation applies. However, there are still three additional questions that have to be answered:

Question 4: Does the product under consideration fit the following description?

— 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) of Regulation (EU) 2017/745 and of those referred to in the first paragraph of Article 2(1).

Answer: If the answer to questions 1, 3 and 4 is yes, the product fulfils the definition of a medical device and the regulation likely applies. However, there are still two additional questions to be answered.

Question 5: In addition to fulfilling the definition of a medical device, does the product under consideration also fulfil the definition an in vitro diagnostic medical device as defined in Annex 2 (2) of Regulation (EU) 2017/746? If the answer is yes to question 5, the product fulfils the definition of an in vitro diagnostic medical device, Regulation (EU) 2017/746 applies and not Regulation (EU) 2017/745.

For the majority of products, the five questions above will usually be sufficient to determine whether or not the regulation applies. However, there is still one further question to be answered.

Question 6: Is the product under consideration listed in Annex XVI?

Answer: If the answer is yes to question 6 the regulation applies.