ZP is a contract developer and contract manufacturer of diagnostics, including veterinary diagnostics. As part of our full service offering ZP also provides Regularory Affairs Quality Assurance (RAQA). The notes below are not legal advice and please reach out to ZP to discuss this note and to also discuss ZP’s SenseItAll platform for veterinary diagnositcs.
Veterinary medical devices and their regulation have been a grey area. Devices do not fall under the scope of either the In Vitro Diagnostic Regulation (IVDR) or Medical Device Regulation (MDR). However, diagnostic test kits would likely fall under the scope of ‘veterinary medicinal product’ according to the EU Veterinary Medicinal Products Regulation, as its purpose is to be used in animals for making a medical diagnosis. The competent authority responsible for granting market authorization in the UK is the Veterinary Medicines Directorate (VMD), and in Northern Ireland, it is the Health Products Regulatory Authority (HPRA).
A test kit is likely to fall under the scope of the Regulation because product classification under every regulation depends on the intended use. The definition of intended use provides a framework of responsibility for the Legal Manufacturer, whether it is the person/legal entity placing the product on the market or, if reselling the kit, the end buyer placing the final product on the market. The legal manufacturer may specify the intended use as ‘indication only, not intended for diagnosis,’ which may lead to lower regulatory hurdles. This would limit the marketability of the device, but some manufacturers declare their intended use in a way that lowers the device classification and regulatory burden.
Nonetheless, manufacturers are likely to require some form of market authorization and should check with the VMD for specific requirements. They may be asked to present a technical file, and the Veterinary Medicinal Products Regulation stipulates key essential requirements, such as minimum quality and safety, and what to include in the user manual. Manufacturers, such as vHive in the animal test kit space, would use this regulatory guide alongside directives like the Low Voltage Directive/EMC directive to determine what to include in their technical file. Result validation studies would also be conducted to ensure efficacy.
Basic electrical safety of the hardware is necessary, and if the apparatus is not for human use, limited safety testing and self-declaration may apply, especially for low-voltage devices. For instance, a USB-powered item with a battery should have a certified battery (e.g., IEC 62133 approved for li-ion rechargeable). Compliance with directives such as EMC Directive, RoHS, REACH, and others for CE marking is essential, and many companies have already undergone this process for their other hardware.
If the kit is intended for humans, then IVDR would apply, and the company would need a Notified Body. Alternatively, if there is a resale to an end-manufacturer, it could be the responsibility of the end-legal manufacturer that brands the product and places it on the market.
In essence, contacting the VMD is an appropriate step, and the regulatory pathway broadly depends on the intended use and the legal manufacturer.
