Drug products versus medical devices - where are the differences?

Both, drug products and medical devices, serve therapeutic and / or diagnostic purposes to be used in humans. Market authorization and manufacturing of products in both categories are subject to strict laws.

Depending on the classification of the product, the manufacturing process must be strictly controlled and validated, with different regulations applying to medical devices and pharmaceuticals: the Medical Devices Act and the Medicinal Products Act. Therefore, it is of utmost importance to define and distinguish between the two product categories. The biggest difference here is the respective mode of action. This always refers to the intended main effect - i.e. the effect for which the product was originally developed.

The distinction between pharmaceuticals and medical devices is not always clear-cut. In principle, substances that intervene in the body's metabolism or immune system can be classified as drug products. They thus mediate their effect pharmacologically, metabolically, or immunologically. These definitions are laid down by the Medicinal Products and Medical Devices Act in Germany or throughout the EU via certain EU directives (especially 2001/83/EC for drug products for human use and 93/42/EEC for medical devices). However, a case-specific analysis of the product is often necessary to distinguish between medical devices and drug products. This may result in national exceptions. According to the EU directive, in vivo diagnostics such as a contrast medium is a medical device, whereas in Germany it is classified as a pharmaceutical. The market authorization process of new drugs in Europe and the USA is associated with costly and time-consuming clinical trials. Approved and marketed drug products are subject to continuous controls. In this context, we should also mention the qualified person for pharmacovigilance, who collects and evaluates all reports of side effects and risks and coordinates the appropriate actions. It is not uncommon for disputes about whether a product is a pharmaceutical or a medical device to end up in court.

Unlike a drug product, the effect of a medical device must not be pharmacologically, metabolically or immunologically mediated. This means that a medical device must not contain any pharmaceutical active ingredient that falls under the German Medicinal Products Act - if this would be the case, the product would be classified as a pharmaceutical. The effect of medical devices is therefore primarily physical. The range of medical devices is very broad and encompasses e.g. wheelchairs and bandage materials, hearing aids, contact lenses, condoms, pacemakers and artificial joints. Medical devices are divided into four classes depending on the risk assessment: Class I (low risk), IIa, IIb and III (high risk).

With few exceptions, medical devices approved for marketing must have a CE label. A CE label proves that the medical device complies with the relevant regulatory requirements, considering the intended purpose of the product. Three important European directives are considered: 98/79/EEC for in vitro diagnostic medical devices, 90/385/EEC for active implantable medical devices and Directive 93/42/EEC for other medical devices.

Among both, medical devices and pharmaceuticals, there are products that are primarily intended for use by physicians. Examples of drug products include vaccinations and infusions to be administered by physicians. Medical devices include, for example, X-ray machines or dental prostheses that are used or fitted exclusively by physicians. However, there are also products intended for use by the end user, i.e. the patient himself. Examples for pharmaceuticals are the drug products everyone has at home such as headache tablets, diarrhea remedies and cold remedies. Examples of medical devices include amongst others sterile bandage materials and contraceptives such as condoms.

So-called combination products represent a special case: They are defined by the combination of a drug product, a biological product and / or a device under the condition that the products are related and must serve a common purpose. Examples of combination products are pre-filled insulin or adrenaline syringes (so-called "pens" for self-injection), transdermal patches (nicotine patches, corn patches), condoms with spermicide coating, but also photosensitizing drug products together with the associated activating light source. Although drug products and medical devices are combined here, the manufacturer of the product must decide on the category – the categorization of one product being a drug product as well as a medical device is not permitted. Once again, the product is defined according to its main intended effect, although this often becomes a matter of dispute in case of combination products. A good distinction can be made between products in which the medical device forms a fixed unit with the drug product, thus which cannot be reused (so-called kits). We will illustrate this with the example of a syringe: Insulin syringes intended for single use fall under the Medicines Act (= drug product), as they form a fixed unit, while refillable insulin syringes are considered medical devices. Here, the separately available "filling" counts as drug product.