Should veterinary medical devices be CE-marked?

01/08/2022

When a product falls into the field of application of a directive of the so called “new approach” providing for its application, a product must mandatorily present the CE marking. On the contrary, if the product does not fall into the scope of this kind of regulations, then it may not include it.

In the case of medical devices, the current Directive 93/42/EEC regulating them refers only to products intended to be used in humans; consequently, everything used for medical activities on animals is excluded from the field of application. Although such criterion is quite clear, there are often products on the market classified as “veterinary medical devices”.

This definition refers, for instance, to bands, patches, syringes for animals, but also beds, prostheses, diagnostic kits, and medical equipment of various types, all identifiable as medical devices, but intended for use in animals. There are products, such as surgical instruments, that do not differ from those for human use, and that are therefore medical devices with full rights. However, when used in animals, these run the risk of falling into an off-label use, that is not in compliance with Directive 93/42/EEC.

The field further extends if substance-containing medical devices are considered, such as ointments, creams and solutions with a non pharmacological mechanism of action. In this case, the lack of a reference regulation results in this products to be defined as veterinary medicines, making them subject to strict regulations (Directive 2004/28/EC), including a mandatory MA, that is not provided for medical devices.