Should veterinary medical devices be CE-marked?
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.
Definition of veterinary medical devices
Several products for animals, that are not clearly identifiable or analogous to medical devices, are often inappropriately defined as “veterinary medical devices”, in spite of being non harmonised products, that is not concerned by a specific regulation. The definition of veterinary medical devices is therefore not a legal one, but it comes from the definition of medical device (for human use) by analogy. This fragmented situation generates confusion among manufacturers, for whom it is not clear when to refer to Directive 93/42 and apply the CE marking. A similar situation is that of the so called “veterinary IVDs”, that many manufacturers try to classify based on the definition of IVD in Dir. 98/79/EC.
The CE marking is not provided for products not falling into the field of application of the directives that require it mandatorily, so a veterinary medical devices should be marked only if including mechanical and/or electrical components. In this case, the product could fall into other directives providing for mandatory marking, but in no case it is mandatory to comply with the requirements provided for by the medical device Directive (or Regulation).
Products for animal care that are not medicinal products shall follow Directive 2001/95/EC on “general product safety”. Manufacturers shall clearly report on the label any information regarding the identification of the product, the manufacturers’ details, and any sufficient information on the materials used – with specific indication of potentially hazardous materials – thus ensuring the product safety.
In case the product cannot be easily classified, and in case of any doubt, the obligation of the manufacturers to market products that are safe for users and comply with the essential requirements provided for by the existing European directives, when applicable, still apply.
Written by: Sofia Tabacco
Foto di jacqueline macou da Pixabay
