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Veterinary Medical Device Regulatory Status
Given the absence of regulation on the matter, both at a community and national level, the document developed intends to make the use of some medical devices for veterinary treatments easier. The Guidelines provide a technical consultation tool that allows manufacturers, or in any case, operators who intend to introduce them into the veterinary sector, to carry out a classification assessment of the device.
The Guidelines also highlight the safety rules for the protection of both the animal patient and the user, typically understood as the veterinarian or the owner of the animal.
Since there is no legal definition of "veterinary medical device," the Guidelines provide one by drawing, where relevant, from the European regulation of devices for human use and from Regulation (EU) 2023/988 of imminent application, which will strengthen the safety of consumers who use products other than veterinary medicines and foods marketed in the EU.
Definition of “device for veterinary use”
Therefore, the Guidelines define "device for veterinary use" as the instrument, apparatus, implant, software or reagent, material, or other article intended by the manufacturer to be used, alone or in combination, on the animal for the purposes of:
- diagnosing, preventing, controlling, treating, or mitigating a disease;
- diagnosing, controlling, treating, attenuating, or compensating for an injury or a handicap;
- studying, replacing or modifying the anatomy or a physiological or pathological process of the animal;
- intervening in conception.
In addition, the device for veterinary use does not exert the main action for which it is intended through pharmacological, immunological, and/or metabolic means, in or on the body of the animal.
Other relevant definitions are given in the Guidelines in order to clarify the different roles of the stakeholder involved and the different kinds of devices: diagnostic, active, implantable, and substance based.
Risk Management Approach
The Guidelines provide guidance on the risk management system to be followed in order to develop, manufacture and put on the market the Veterinary Medical Device.
A risk management system should be set for each product in order to detect and minimize all the identified risks related to the use of the device itself.
In addition, risk control measures should be set by the manufacturer in order to manage the product’s safety profile once it is on the market.
Labelling
With the Guidelines, the authority wants to harmonize the labelling of these products by providing a list of information to be included on the product label and in the instructions for use.
Minimum information required in the product label are:
- Product name
- Manufacturer information/contact
- Country of origin
- List of dangerous substances included in the device
- Material/substance used in the manufacturing (composition)
- Instruction for use
- Destination of use
- Expiry date/shelf-life information
- Manufacturing date if expiry date is not provided
- Veterinary use specified
Safety Approach
The Guidelines provide general indications about the safety and performance of devices for veterinary use, hoping that the same, and the related manufacturing processes, are designed in such a way as to eliminate or reduce, as much as possible, the risks of infection for animals, users and, where applicable, other persons.
The risk management process is the fulcrum of the management of the safety profile of the product; each risk identified for animals and users should be evaluated, minimized, and controlled as described in the Guideline.
Conclusion
In order to develop, manufacture and market the Veterinary Medical Devices in compliance with the Guidelines, specific knowledge of Medical Device risk management and Veterinary Medicine is needed; the manufacturers must review the labelling of their products that are on the market and the available technical documentation in order to guarantee the efficacy and safety for the animal, the user, and the environment. A complete risk assessment for each product should be performed and documented in order to guarantee efficacy, quality, and safety of the devices.
Sources:
“Linee guida nazionali sui requisiti generali di sicurezza e di prestazione dei dispositivi per uso veterinario” (0020935-03/07/2024-DGSAF-MDS-P)
