Is my product a medical device? How to determine if your product requires a CE Mark in the EU
If you want to know whether your product is considered a medical device in the EU, and especially, if you do have doubts on this matter, do read on. The answer to what may appear to be a simple question is in some cases quite complex.
Determining the regulatory regime that applies to your product may pose a challenge. Cases that are not easily categorized do exist and the final decision is based on a case-to-case assessment, sometimes even going as far as a court ruling. It is safe to assume that you are not the first person to have insecurities concerning the applicability of regulatory regimes, not just because many different products are regulated in the EU but because your product might be subject to overlapping regimes. In the following section the challenges and the helpful documents to determine whether a product falls within the scope of the EU medical device framework are outlined. To make this matter more urgent, we are already halfway through the transition period of a newly adopted, more stringent Medical Device Regulation (MDR), which introduces a slight extension of the medical device definition.
How is the legal framework helpful for the medical device qualification?
The legal frameworks, MDD as well as MDR, provide definitions of medical devices, which in theory should make it possible to qualify products as medical devices. If you make a medical claim for your product, chances are good that it is a medical device and taking a very close look at the legally binding definition is indispensable. As the MDR has a wider scope of medical devices (and is the decisive basis for a qualification if you ask this question at this point of time), it makes sense to look at the definition of medical devices in Article 2 (abbreviated): ‘medical device’ means any software 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 definition is helpful when you think of it being related to the intended use of your product (which brings you back to your medical claim), which is ultimately the decisive element of the qualification. Please note that the MDR includes a list of products without an intended medical purpose in Annex XVI to which the regulation also applies. Assuming you have qualified your product as a medical device, it needs to be classified properly and this is where the legal texts (and a legally not binding guidance document) provide assistance: the classification rules and the MEDDEV 2.4/1 can be used to understand the meaning of the definition. The legally binding definition of medical devices is found in Article 2 of the MDD, the classification rules in Annex IX. The legally binding definition in the MDR is article 2, the classification rules are found in Annex VIII.
What are reasons a qualification under the MDR might be not as simple as you think?
Despite the definition, there are some cases that are still at the border of the regulations. There are several reasons for difficulties, but let us consider innovation, digitalization, and advances in medical technology leading to an increase of combination products and medical software for now. The good news is that additional guidelines have been issued: the so-called Borderline Manual and MEDDEV 2.6/1 for the qualification of stand-alone software, the bad news is that those documents are currently only applicable in connection to the MDD, not the MDR. As the Medical Devices Expert Group (MDEG) on Borderline & Classification is quite active and updates the manual regularly, it may remain relevant. It is foreseeable that cases regulated under the MDR will be included soon. Additionally, the changes the MDR brings related to the qualification mainly concerns medical software and cosmetic products.In borderline cases, it is not clear from the outset which regulation applies and if a product is a medical device in the first place. The Borderline Manual lists cases divided in to the different sections, highlighting where difficulties lie:
- Medical device/In-Vitro Diagnostic Medical Device – Medical Intended purpose
- Borderline In-Vitro Diagnostic medical device
- Borderline Active Implantable Medical Device – Medical Device
- Borderline Medical Device – Medicinal Product
- Borderline Medical Device – Biocides
- Borderline Medical Device – Cosmetic Products
- Accessory to a Medical Device or an In-Vitro Diagnostic Medical Device
- Software and mobile applications
The Borderline Manual is an important interpretation of the regulatory requirements regarding the qualification of medical devices and the distinction from other products. The decision whether or not a particular product constitutes a medical device may be guided by reference to the Borderline Manual. Innovation and digitalization of health technologies are the driving forces of the need to expand the interpretation of the medical device definitions, as laid out in the MDD and MDR, making additional guidelines and updates necessary.
EU court ruling confirms the interpretation of legislative provisions for medical software
The use and importance of medical software in today’s healthcare practices has increased immensely in the last few years. Even though the MDD was not phrased with medical software in mind, software is regulated under the directive with the amendment of the definition made in Directive 2007/47/EC. The MEDDEV 2.6/1 document was created to define the criteria for the qualification of stand alone software as a medical device as and the application of the classification criteria to such software. If your product is a software, this is the document you want to consult for qualification questions. But the guidance points back to the definition of a medical device, as it states that software must have a medical purpose in order to be qualified as a medical device. The criteria considered as relevant in guidance documents such as the MEDDEV 2.6/1 are not legally binding. But it is instructive to take into account the decision of the Court of Justice of the European Union in the one case on legal classification of software as a medical device. The court confirmed the interpretation of the legislative provision by considerably relying on the criteria specified in the MEDDEV 2.6/1 document. This confirms that this guideline is a useful tool to interpret the legal requirements relating to the qualification of medical devices as such and that it is reasonable to rely on it. Software that is considered a medical device under the MDD will also be treated as a medical device under the MDR; there is not much change when it comes to the qualification. However, the MDR does add a more stringent regime when it comes to the classification. This is because almost all software with a medical claim is classified as Class IIa or higher under the newly introduced classification rule for software (Rule 11).
In a nutshell: what tools are available to assist you and who do you turn to if those do not provide a conclusive answer?
If you suspect that your product is a medical device, we advise you to consult the legal framework and the available guideline documents such as the mentioned MEDDEVs, the Borderline Manual, and even the precedent court ruling. National competent authorities also release guidance documents, the ones mentioned above are issued on EU level. In very difficult cases, it is possible to request support from a notified body or even the national competent authority. If you believe that your product could be a medical device of the lowest risk class, the request for support should be sent to the national authority. If a higher risk class comes into question, the first request for support should be addressed to a notified body, which could still involve the competent authority, if necessary. A framework intended to cover a plethora of devices with different characteristics and specifications naturally leads to very distinctive questions depending on the device in question. They cannot be answered in a blog post, but this is a reminder of the importance of assessing the regimes in which your product may or may not fall to ensure compliance.