BfArM - Federal Institute for Drugs and Medical Devices
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If you use the services of this provider, it is possible that usage data will be collected and, if necessary, stored in server logs.The BfArM has no influence on the type and scope of the transmitted or stored data. Go to LinkedIn
Basic information
What is a medical device?
Medical devices are products used for the diagnosis, prevention or treatment of diseases, injuries or disabilities in humans.
Medical devices have different manifestations.
These include, for example, apparatus, devices and instruments. However, there are also substances that meet the criteria of a medical device - and software can also be a medical device.
For the full definition applicable in the European Economic Area (EEA), see Article 2(1) of the European Medical Devices Regulation MDR (2017/745). Laws and Ordinances
In addition to the member states of the EU, the EEA includes some states of the European Free Trade Association: Norway, Iceland and Liechtenstein. For the medical devices sector, there is also a corresponding agreement with Turkey. (Status January 2023)
In vitro diagnostics
A special group of medical devices are in vitro diagnostics (IVDs).
IVDs are used to examine sample material derived from the human body, e.g. blood, urine or saliva.
For the full definition applicable in the European Economic Area, see Article 2(2) of the European In Vitro Diagnostic Medical Devices Regulation IVDR (2017/746). Laws and Ordinances
In vitro diagnostics (IVD) are by definition medical devices. To simplify matters, one often speaks of medical devices on the one hand and IVDs on the other. Regulations for medical devices (excluding IVDs) are laid down in the European Medical Devices Regulation, regulations for IVDs in the European In Vitro Diagnostics Regulation. Laws and Ordinances
Which products are not covered by the definition?
"Medical device" is not the umbrella term for all products used in medicine.
Before a product is allowed on the market, its legal status must be clarified. The legal status determines which legal requirements have to be applied in order to place the product on the market and which authority(ies) is/are responsible.
Products with similarities to medical devices are, for example, medicinal products, cosmetic products, personal protective equipment, foods and biocides.
Medicinal products
Medical devices must be distinguished from medicinal products among other things.
Medicinal products are also used to treat or diagnose diseases. In contrast to medical devices, however, medicinal products have a pharmacological, immunological or metabolic effect. It is not always obvious whether a product is a medicinal products or medical device.
Caution: The term "Medizinprodukt" is German for medical device. The German term for medicinal product is "Arzneimittel". There are more product groups that may have similarities to medical devices but are used for a different purpose.
Cosmetic products
Cosmetic products have a different purpose than medical devices: They are not primarily used for the treatment of diseases, but e.g. for cleansing, changing the appearance or maintaining a good condition.
Lipstick, deodorant, shaving cream or perfume are easy to identify as cosmetic products. For other products, the classification is not always clear. For example, toothpastes or sun creams are usually cosmetics. In individual cases, however, they can also be medical devices.
The BfArM has no responsibilities in the area of cosmetic products. For more information on cosmetics, see the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL):
Personal protective equipment is used in occupational safety. They primary purpose is to protect the wearer. For the classification as personal protective equipment, it is irrelevant whether the wearer is a medical professional.
Medical face masks (surgical masks, mouth-nose protection) are medical devices. Their primary purpose is to protect patients from droplets. They thus serve as external protection.
Particle-filtering half masks (e.g. FFP2 masks) are personal protective equipment. They are used to protect the wearer from inhaling dust or aerosols. They serve as self-protection.
The BfArM is not involved in the area of personal protective equipment. For more information on personal protective equipment, see the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, BAuA):
Foods include, for example, dietary supplements. They serve the purpose of supplying the body with additional vitamins, minerals and other substances to supplement the normal diet. They are not intended to treat or relieve diseases.
The BfArM has no responsibilities in the area of foods. For more information on foods, see the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL):
Biocides include, for example, disinfectants. A disinfectant can also be a medical device, but only if its primary purpose is to disinfect medical devices. The primary purpose has to be indicated by the manufacturer.
The BfArM has no responsibilities in the area of biocides. For more information on biocides, see the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, BAuA):
