Medical devices are sometimes not easy to distinguish from different product categories such as machines, commodities, medicinal products, food supplements or cosmetics without their intended purpose. Questions about the demarcation are therefore not uncommon. Consumers and manufacturers often find it difficult to make an allocation in the case of supposedly comparable properties.
According to Article 2 of the Medical Device Regulation (EU) 2017/745 (MDR), the medical purpose of the product is decisive for its classification as a medical device:
‘Medical device’ means 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 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.”
Influence of the intended mode of action
Furthermore, the intended main effect in or on the human body must not be achieved by pharmacological, immunological or metabolic means. For this reason, mechanical, electrical, magnetic, chemical or other physical-technical mechanisms of action are often used in medical technology.
Classical, technical forms of application in connection with a medical purpose can often be clearly categorized, whereas the mechanism of action of medical devices made of substances or combinations of substances cannot be assigned quite so easily. Modes of action that cannot necessarily be assigned to medicinal products and follow chemical or physical laws can serve as the basis for medical devices. All products whose regulatory status is not clear belong to the so-called borderline products. Here, the “Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices” can be used as a guide, or you are welcome to submit an enquiry via our contact form. We will be happy to support you in finding the appropriate regulatory direction.
Via Article 51 paragraph 2 as well as § 6 MPDG, the competent higher federal authority of the Member State in which the manufacturer has his registered place of business is also authorized to bring about a decision. At the request of a Member State, the Commission may also decide on the application of Annex VIII to a specific device, device category or device group after consulting the MDCG. For public health reasons, the Commission shall also be entitled to take a decision derogating from Annex VIII. The latest scientific findings or information from vigilance and market surveillance may provide decisive impetus in this regard (cf. Article 51 (3)).
Other medical devices with CE mark
Medical devices also include:
- products for contraception or promotion of conception,
- products specifically intended for the cleaning, disinfection or sterilization of contraceptives or devices for promoting conception and all products listed in Annex XVI.
Disinfectants are a special group with regard to classification. If they are intended for the disinfection of floors or cabinets and surfaces, then they are biocides. If they are used for hand disinfection, they are medicinal products and if the microbial status of medical devices is changed by their use, the Medical Devices Regulation applies.
A question of ingredients
However, the demarcation between medical products and food supplements with regard to their health-related advertising claims is also limited. Here it may be worthwhile to rummage in the legal foundations from other areas of law at .
An identification of the intended mechanism of action is therefore indispensable and must always be presented in a product-specific manner. The demarcation between medicinal products, foodstuffs and medical devices can become sufficiently complex.
The MDR describes the classification of medical devices with the help of Article 51 in Chapter V and 22 classification rules in Annex VIII. In principle, the classification of medical devices is based on the intended purpose in connection with the risks of the product (Article 51 Paragraph 1).
Based on this, the classification is made into 4 risk classes:
- Class I (m, s, r)
- Class IIa
- Class IIb
- Class III
Class I products are associated with the lowest risks and class III products with the highest risks. For differentiation, there are general classification rules for both invasive and non-invasive devices as well as for active medical devices. Rules 14 to 22 are dedicated to particular aspects of classification where specific product characteristics stand out.
An invasive device is intended to be used in the human body. The only distinction is whether the medical device enters the body through a body orifice or through a surgical intervention. The MDR defines a body orifice as all natural openings of the body and the outer surface of the eyeball on the one hand and surgically created permanent openings on the other.
If a surgical procedure is performed to introduce an MP into the body, the term surgically invasive is used (see Annex VIII, Chapter I, Section 2, No. 2.2 MDR).
An active medical device (cf. Article 2 No. 4 MDR) is characterised by the fact that its operation depends on a source of energy and that an effect is achieved by means of a change in the density or conversion of this energy. Exceptions are the energy types human power and gravity. However, if a device is used to transfer energy, substances or other elements between an active device and the patient, this is not considered to be an active device if no significant change of energy, substances and parameters takes place.
Software is generally considered an active product.
Products that cannot be classified based on their invasiveness or activity or that have special properties can be classified using rules 14 to 22.
These include, for example, products,
- with a medicinal substance as an ingredient,
- for contraception,
- for protection against sexually transmitted diseases,
- especially for disinfecting or cleaning MP,
- especially for recording X-ray images,
- in relation to non-viable or dead tissues or cells of human or animal origin or their derivatives
- with nanomaterials in connection with internal exposure
- for the processing of medicinal products by inhalation
- from substances or combinations of substances with uptake by the body or local distribution on the body
- with integrated or built-in diagnostic function with simultaneous active, therapeutic application
As an aid to interpretation, the Medical Device Coordination Group has produced a guidance document: MDCG 2021-24 Guidance on classification of medical devices.