Veterinary Devices and Diagnostics within the EMA’s Scope? What the Veterinary Innovation Day Confirmed

September 2025, originally published on LinkedIn and expanded for the website

I had the opportunity to attend the second Veterinary Innovation Day organised by the European Medicines Agency (EMA) in Amsterdam in March 2025, representing Diagnostics for Animals, the federation of veterinary diagnostic manufacturers. This event, dedicated to innovation in veterinary medicines, was an opportunity to clarify a question that regularly comes up from the companies I support: do veterinary medical devices and veterinary diagnostics fall within the EMA’s scope?

What the exchanges confirmed

The Q&A sessions provided clear answers from EMA representatives on several questions raised by participants:

• Veterinary medical devices do not fall within the scope of the EMA or the Veterinary Medicines Regulation (2019/6). No plan or intention to include them has been announced. One notable exception: if a medical device for example a diagnostic kit is used in combination with a veterinary medicinal product and it is essential to establish the diagnosis before starting treatment, a request for a meeting with the Innovation Task Force (ITF) could be considered on a product-specific basis by a company.
• There is also no specific procedure or guideline for the development of an innovative veterinary diagnostic kit in contrast to what exists in human health. This regulatory gap remains a concrete challenge for companies in the sector.

A perspective to watch

One notable development: the EMA indicated that it anticipates the future development of a regulatory framework for rapid veterinary diagnostic tests, particularly pen-side tests enabling rapid antibiotic selection. This initiative is part of the fight against antimicrobial resistance and is included in the EMA’s work plan. A signal worth monitoring for veterinary diagnostics manufacturers.

What this means for companies

For companies developing veterinary devices or diagnostics, this regulatory context both poorly mapped and evolving, makes early strategic analysis all the more important: identifying the applicable framework, anticipating developments, and building a solid market access strategy before committing significant resources.

→ Are you developing a veterinary device or diagnostic and wondering about the applicable regulatory framework? A One Health Compliance Technical Day is designed to address these questions in a structured way, in one day, with your team.

Sandra Dejean, PharmD – Founder of One Health Compliance

References:

• EMA Veterinary Innovation Day, mars 2025. [Online]. Available at: https://www.ema.europa.eu/en/events/ema-veterinary-innovation-day#related-content-71835.
• Dejean S. Do Veterinary Devices and Diagnostics Fall Within the Scope of EMA? LinkedIn, September 2025. Available at: https://www.linkedin.com/posts/sandra-one-health-compliance_regulatorywatch-veterinarydevices-veterinarydiagnostics.
• © Aude Lemaitre / One Health Compliance