“Is my product a medical device?” The question seems simple. In practice, it is often trickier than it looks.
Is a health-tracking software a medical device? Does an anti-acne cream fall under the MDR or the cosmetics regulation? Can an aesthetic product with no therapeutic purpose still be subject to the MDR? Does an accessory have to be CE-marked like a device?
Regulatory qualification is a decisive step. It determines the applicable framework, the manufacturer’s obligations, whether or not medical CE marking is required, the risk class, the possible involvement of a notified body, the content of the technical documentation and the post-market surveillance requirements.
Getting the qualification wrong can therefore have serious consequences: delayed placing on the market, reclassification by an authority, documentary non-conformity, changes to commercial claims, or even withdrawal or suspension from the market.
Why qualification is a critical step
Qualification consists of determining whether or not a product falls within the scope of Regulation (EU) 2017/745 on medical devices, known as the MDR.
This analysis must take place very early, ideally before freezing the product strategy, the marketing claims, the clinical model and the development plan. It must not be treated as an end-of-project formality.
Indeed, the same technology may fall under several frameworks depending on its claimed purpose. A sensor, a mobile application, a dressing, a software solution or a substance may be subject to the MDR in one context and not in another.
Qualification is therefore not only linked to the physical nature of the product. It depends above all on its intended purpose, its claims and its principal mode of action.
The definition of a medical device in the MDR
Article 2 of the MDR defines a medical device as 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 specific medical purposes.
These purposes notably include:
- the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
- the diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability;
- the investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
- the provision of information by means of in vitro examination of specimens derived from the human body, subject to the interface with the IVDR where the product falls under in vitro diagnosis.
The MDR also specifies that a medical device does not achieve its principal action by pharmacological, immunological or metabolic means, even though such means may contribute to its function.
This criterion is essential in distinguishing certain medical devices from medicinal products, cosmetics, food supplements or other categories of regulated products.
The MDR also considers that certain families of products are deemed to be medical devices, such as:
- devices intended for the control or support of conception (condoms, intrauterine devices, etc.);
- products intended for the cleaning, disinfection or sterilisation of medical devices and their accessories.
It is important to note that certain products with no medical purpose, as provided for in the definition of a medical device, are nevertheless subject to the requirements of the MDR. The detailed list of these specific products is given in Annex XVI of the MDR and includes, notably but not exclusively, contact lenses, implants for the modification of anatomy, injectable dermal fillers for wrinkle correction, and equipment used to reduce, remove or destroy adipose tissue, etc.
The central criterion: the intended purpose claimed by the manufacturer
The determining criterion is the intended purpose of the product, that is to say the intended use claimed by the manufacturer. This intended purpose is not limited to a sentence in the instructions for use. It is inferred from all the material made available: labelling, instructions for use, website, commercial brochure, sales pitch, demonstrations, training materials, software interface, advertising messages and technical documentation.
A product may therefore change status depending on its claims. To illustrate this point, let us compare the following examples:
- A sunscreen intended to protect the skin against UVA and UVB and having a moisturising effect will be regarded as a cosmetic product, whereas a sunscreen intended to protect the skin against UVA and UVB and to prevent actinic keratoses and skin cancers will be regarded as a medical device.
- An application that helps a user track their general physical activity is not necessarily a medical device. On the other hand, an application that analyses symptoms, helps detect a condition, provides diagnostic support or guides a therapeutic decision may fall within the scope of the MDR.
- A bandage sold as a comfort accessory for sport may not fall under the MDR. The same product, claimed for the treatment or alleviation of a venous condition or an injury, may become a medical device.
Qualification often comes down to wording. A poorly controlled marketing claim can be enough to tip a product into a more demanding regulatory framework.
What distinguishes a medical device from another regulated product
MDR qualification generally involves three successive questions.
First question: is the product intended for a medical purpose within the meaning of the MDR?
Second question: is its principal action achieved by non-pharmacological, non-immunological and non-metabolic means?
Third question: does it instead fall under another regulatory framework, for example medicinal products, cosmetics, food supplements, personal protective equipment, the IVDR or a general consumer product?
These boundaries are not always obvious. European and national authorities regularly publish guidance and examples of borderline cases to help harmonise interpretations. These documents are useful, but they do not replace a specific analysis of the product, its intended purpose and its claims.
The borderline cases that trap manufacturers
Software and health applications
Software is one of the most frequent cases. Software may be a medical device if it is intended for a medical purpose. It is not the software medium that triggers the MDR, but the claimed function.
Software that merely stores data, allows appointments to be booked or displays general wellness information will not necessarily be qualified as a medical device.
On the other hand, software that analyses patient data to detect a disease, recommend management, calculate a clinical score or influence a medical decision may be qualified as medical device software. The MDCG 2019-11 Rev.1 guidance provides a method for the qualification and classification of software under the MDR and the IVDR.
Cosmetic products
The boundary between cosmetics and medical devices depends largely on claims and mode of action. As seen above, a product claimed to moisturise, cleanse, perfume, protect or modify the appearance of the skin falls in principle under the cosmetics framework, provided its claims remain cosmetic. On the other hand, a product claimed to treat, alleviate or prevent a skin condition may shift to another framework, including the MDR or medicinal products depending on its mode of action. For example, a claim to treat a dermatological condition must be analysed with caution.
Food supplements and wellness products
Nutritional products, food supplements and wellness solutions are not medical devices simply because they relate to health.
A product intended for general comfort, wellness or the maintenance of normal physical fitness does not necessarily fall under the MDR. But if the manufacturer claims an effect on a disease, an injury, a disability or a pathological state, the qualification must be reassessed.
General-purpose products
An everyday item may become a medical device if its intended purpose is medical.
This is the case, for example, of certain supports (a seat cushion vs a pressure-ulcer prevention cushion), assistive devices, compression products, support devices (a comfort belt vs a lumbar stabilisation belt) or measuring instruments (a household thermometer vs a forehead thermometer). The product itself may seem ordinary, but its claimed use and the context of use may bring it within the scope of the MDR.
Annex XVI aesthetic products
One point is often misunderstood: not all products subject to the MDR are necessarily medical devices in the strict sense of the Article 2 definition.
As seen above, the MDR also covers certain groups of products with no medical purpose listed in Annex XVI, because of their similarity to medical devices in terms of functioning and risk profile. This notably concerns certain aesthetic products, such as implants or products introduced into the body to modify the anatomy, subject to the categories listed and the applicable common specifications.
Two analyses must therefore be distinguished: qualification as a medical device within the meaning of Article 2, and the application of the MDR to certain products with no medical purpose under Annex XVI.
Accessories to medical devices
An accessory is not necessarily a medical device in itself. Article 2 of the MDR defines an accessory as an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical devices to specifically enable them to be used in accordance with their intended purpose or to specifically and directly assist their medical functionality.
This category is important, because accessories are subject to the MDR. They must therefore be qualified, classified, documented and CE-marked in accordance with the applicable requirements.
Accessories and products with no medical purpose: two points not to confuse
Two confusions come up frequently.
The first is to believe that a product with no medical purpose always escapes the MDR. This is false for certain Annex XVI products, which may be subject to the MDR despite an aesthetic or non-medical purpose.
The second is to consider that an accessory is a secondary product and therefore less regulated. This is also misleading. An accessory to a medical device may be subject to comparable requirements in terms of demonstration of conformity, even if it does not itself meet the definition of a medical device.
These distinctions must be documented in a clear qualification note, because they condition the rest of the regulatory strategy.
How to secure an MDR qualification
To secure the qualification of a product, the manufacturer should formalise a documented analysis. This analysis may include:
- the description of the product and its technology;
- the claimed intended purpose;
- the intended users and patients;
- the indications, contraindications and claims;
- the principal mode of action;
- the associated communication materials;
- the alternative regulatory frameworks considered;
- the qualification conclusion and its justification.
In case of doubt, the manufacturer may rely on the MDCG guidance, the European manual on borderline cases and the resources of the ANSM. In France, the ANSM points out that qualification and classification are essential steps in determining the applicable regulation, the conformity requirements and the competent authority.
For sensitive cases, an approach to the competent authority may be considered. This step must be prepared seriously, with a clear description of the product, its mode of action, its claims and the supporting justification.
Key takeaways
MDR qualification rests first and foremost on the intended purpose claimed by the manufacturer. A product is not qualified solely by its form, its technology or its place of use.
Borderline cases are frequent: software, health applications, cosmetics, wellness products, aesthetic products, accessories, substances and general-purpose products.
Qualification must be documented early, before freezing the commercial claims and the placing-on-the-market strategy. A qualification error can call into question the entire regulatory pathway of the product.
Regulatory source: Article 2 of Regulation (EU) 2017/745 — EUR-Lex