Demarcation of products

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.

Special rules

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.