Delineation
The fact that medicinal products, food supplements and medical devices are not one and the same is often known only to experts. However, there are important differences between the categories, which concern, for example, legislation and regulatory requirements. This article refers primarily to the so-called , which are similar to medicinal products. In addition, medical devices include many other products – for example, adhesive plasters, blister plasters, condoms, pregnancy tests and other self-tests, heat pads containing iron powder, cold hot packs, blood pressure monitors, blood glucose monitors, blood glucose sensors, alcohol swabs, syringes, needles, contact lens solution, defibrillators, pacemakers, implants, software, and MRI equipment.
Fields of application and effects
Similar to pharmaceuticals, medical devices are used to diagnose, prevent, monitor, alleviate and treat diseases. However, they exert their main effects through a physical or physicochemical effect rather than through a pharmacological, immunological, or metabolic mechanism. However, their mode of action may be supported by a pharmacological contribution. Physical in this context means, for example, moistening in the case of dry eyes or a dry mouth. A pharmacological effect, on the other hand, is usually based on an interaction with a drug target, such as a receptor, an enzyme, or a transporter.
Examples
The following list shows typical examples of substance-derived medical devices:
- Capsules for weight reduction in obesity.
- D-mannose for the prevention and treatment of cystitis.
- Lozenges and sprays against hoarseness, cough irritation and scratchy throat.
- Saliva substitutes for dry mouth
- Physical means against head lice
- Creams and ointments against eczema
- Pastilles and capsules with simeticone against flatulence
- Tear substitutes against dry eyes
- Gels for the moistening of the vaginal mucosa in case of vaginal dryness
- Pens and solutions against nail fungus
It should be noted that registered drugs are also available for these indications.
Placing on the market
Medical devices also differ from medicinal products in terms of their introduction to the market, known as placing on the market. Medicinal products are approved by a state medicines authority, in many countries by Swissmedic, the Agency for Therapeutic Products. Medical devices, on the other hand, must fulfill a so-called conformity assessment, which is carried out by a recognized private conformity assessment body (so-called notified bodies, ). The conformity assessment determines whether the requirements of the legal regulation for the product are met. If this is the case, the product can be provided with a conformity marking, usually the CE marking. The “CE” symbol on the package clearly indicates that the product is a medical device. Scientific and, in some cases, clinical investigations are also required for medical devices. However, these are usually less extensive than for medicinal products.
Product information
In contrast to dietary supplements, a medical device contains product information (instructions for use) with which the manufacturer informs about the purpose, correct use, precautions and side effects. The specific areas of application may be mentioned. Food supplements, on the other hand, may only be described with health claims, for example iron supplements with the sentence “Iron contributes to the normal formation of red blood cells and hemoglobin.”
Advertising, distribution and remuneration
Advertising for consumer products is generally permitted. The claims must correspond to the statements in the product information. Public products may be offered not only in pharmacies and drugstores, but also in self-service supermarkets. This increases availability, but there is a lack of advice from specialists. As a rule, health insurers do not reimburse for medical products containing substances. Exceptions are possible, for example when taking out supplementary insurance.
