If you are wondering whether you are dealing with a medical device, you need to refer to the definition in Article 2(1) of the MDR. For various reasons (business case, compliance, planning the product launch), it is important to determine in an early stage of the product development process whether you are working with a medical device. So preferably during the ideation or feasibility phase, and at least at the design and before the development phase. Do not procrastinate on this qualification, even though it is a tricky and sometimes “gray” area in discussions, and bite the bullet.
Who determines whether the device is a “medical device”?
Determining correctly whether a device is a ‘medical device’ is a manufacturer’s own responsibility. You cannot address this question, for example, to a government office or a notified body. You can, of course, seek help [see also: Where can I find help?].
How does the qualification work?
It is relevant that the qualification process is documented, both the conclusion (medical device/not medical device) and the reasoning towards this conclusion. Documenting ensures that (i) the reasoning becomes logical, (ii) you are better able to discuss efficiently with others involved and (iii) you are able to prove to, for instance, supervisory authorities why you came to certain conclusions.
To do this, work on a report in which you first describe the “intended purpose”[1]. The second part of the report consists of an analysis of whether the described intended use falls within the ‘medical device’ definition. Specify explicitly which part of the definition matches with the intended use of the device. Involve parties with relevant roles in the qualification process: the determination can best be done by a quality assurance or regulatory assurance staff member. Also try to involve a product specialist, marketing staff member, and possibly a physician as well.
If your device is not a medical device according to the definition in Article 2.1, do another check to be sure it is not still covered by the MDR by looking at Article 2.2 (“accessories to a medical device”) and Annex 16 (certain product groups without a medical purpose that are medical devices nonetheless).
Any tips on “the gray area” and qualification of software?
Qualification of software as a medical device can be tricky. There is valuable guidance from the European Commission for a few borderline devices[2]. It may also be useful to seek comparison with devices with a similar purpose already in use in healthcare. Another possibility is to look up devices with a similar intended purpose in the European database for medical devices (EUDAMED). Also getting second opinions can be useful.
Specific guidance is available for software as a medical device[3]. When in doubt, be sure to look at Figure 1 of this guidance.
Can anyone help me qualify?
Asking advise to a lawyer specialized in the MDR can be considered when in doubt. This can also add a more legal reasoning to the qualification. Partners of d-Health can also seek independent advice from employees of the RUG and UMCG with experience in these issues. Please contact d-Health to get this started.
[1] Art. 2(12) MDR.
[2] See Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022) (europa.eu)
[3] For more guidance, see MDCG 2019-11: Guidance on Qualification and Classification of Software.
