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, in the first place, on whether or not the product under consideration fulfils the definition of a “medical device” given in point (1) of Article 2 of Regulation (EU) 2017/745. And in the second place whether in addition, the product under consideration fulfils the definition of an “in vitro diagnostic medical device” given in Article 2 (2). 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 an IVD device.
In the first place, to first decide if the product under consideration fulfils the definition of a medical device, one must answer the questions implicit in the definition given in point (1) of Article 2 of Regulation (EU) 2017/745:
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. However, there is an additional question that has to be answered:
Question 4: Does the product under consideration fit the following description?
— devices for the control or support of conception;
Answer: If the answer to questions 1, 3 and 4 is yes, the product fulfils the definition of a medical device.
If the product under consideration does fulfil the definition of a medical device, the following questions will determine whether or not the product under consideration additionally fulfils the definition of an in vitro diagnostic medical device. In which case the IVD Regulation (EU) 2017/746 will apply to the product rather than the more general medical device Regulation (EU) 2017/745.
Question 5: In addition to fulfilling the definition of a medical device, is the product under consideration intended to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body? If the answer to question 5 is yes, the product could be an in vitro diagnostic medical device, continue to ask the next question. If the answer to question 5 is no, if the product is not intended to be used in vitro for the examination of specimens, the product is not an in vitro diagnostic medical device and the regulation is not applicable.
Question 6: Is the purpose, for the in vitro examination of the specimens, to provide information on one or more of the following: (a) concerning a physiological or pathological process or state; (b) concerning congenital physical or mental impairments; (c) concerning the predisposition to a medical condition or a disease; (d) to determine the safety and compatibility with potential recipients; (e) to predict treatment response or reactions; (f) to define or monitoring therapeutic measures.?
Answer: If the answer is yes to question 6, as well as to question 5, the product under consideration fulfils the definition of an in vitro diagnostic medical device and the IVD regulation applies.
For the majority of products, the six 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 7: Does the product under consideration fit the definition of a “specimen receptacle” given in Article 2 (3)?
Answer: If the answer is yes to question 7, the IVD regulation also applies.
Finally, it is important to document the rationale for deciding the product under consideration is an in vitro diagnostic medical device or that the regulation applies. As “the rationale for the qualification of the product as a device” is a required item in the Technical Documentation – See Annex II, 1.1 (e).