By Sandra Dejean, founder of One Health Compliance
Based on the webinar held for the Hippolia Cluster (October 2025)

Introduction

In October 2025, I led a webinar for the Hippolia Cluster on a topic that comes up regularly in my conversations with players in the equine sector: how do you assess your level of regulatory compliance and where do you start? [1, 2]

The equine sector offers many opportunities to develop new products — care, wellness or health-oriented. But identifying the applicable regulatory framework for these products can be complex: a product’s status is not always straightforward to determine, and the implications that follow for design, communication and market access are often underestimated.

These 10 questions are designed to explore this landscape. They apply to any company that develops or markets a product for horses — whether a veterinary medical device, a care product, a diagnostic tool or a wellness product.

Why these 10 questions?

They draw on three complementary sources: field exchanges with companies in the sector, nearly 20 years of experience in regulatory affairs, and my practice as a certified ISO 13485 Lead Auditor. Their objective is simple: to help you quickly identify your level of compliance and determine whether you need to act.

The observation behind this approach is clear: an undetected regulatory non-conformity can have direct consequences on a company’s economic viability. Conversely, a well-built regulatory strategy is a genuine competitive advantage and a quality signal for your clients.

Question 1 – Does regulation apply to all equine products?

Yes – and this is often where the surprise begins. Every product placed on the market is subject to regulatory requirements, whether or not it is specifically regulated as a medical device or veterinary medicinal product.

These requirements affect the product from the design stage, the entity that develops and markets it, the associated communication, and post-market activities. The level of requirements varies according to the product’s qualification and the country of sale but it is never zero.

One key point: even a product that is not specifically regulated must at minimum guarantee the safety of the user. And using language or a presentation associated with a specific qualification such as a veterinary medicinal product can engage regulatory liability that the company has not anticipated.

✓ Are you ready? Can you state and justify the qualification of your product?

Question 2 – What is a regulatory strategy?

A regulatory strategy is a roadmap. It is a document that brings together all the requirements applicable to a product in order to place it — and keep it — on the market in a given country. It “translates” these rules specifically for your product: which regulations apply, what tests to carry out, what you can claim, what you must state on the label.

It is not a formal legal obligation as a document but it is an essential best practice. By formalising it, you anticipate, prioritise and avoid costly mistakes.

✓ Are you ready? Do you have — or can you quickly produce — a document listing your product’s qualification, the applicable regulations in each country of sale, the standards to follow and the necessary approvals?

Question 3 – What are the minimum requirements to consider?

Whatever the product’s status, a general approach applies: designing a safe product. This means a design that does not mislead the user, that ensures safety, claims that you can substantiate, sufficient information for the user, and post-market surveillance to take corrective action where necessary.

For more specifically regulated products, the requirements are more detailed: risk analysis, testing according to standards or reference frameworks, scientific and clinical evidence, product verification and controls.

✓ Are you ready? Have you applied these design and development best practices?

Question 4 – What is the link between quality and regulatory compliance?

The two are inseparable. The quality approach — or quality management system (QMS) — involves documenting internal practices, verification methods, and analysing results to ensure the product is safe and objectives are met.

Depending on the product’s qualification, regulation may impose specific quality requirements: good manufacturing practices, QMS certification by a notified body (ISO 13485 for medical devices). Other certifications, such as ISO 9001, can be deployed voluntarily.

✓ Are you ready? Do you have supplier monitoring procedures, product traceability, and quality controls before delivery?

Question 5 – How do you demonstrate product compliance?

Demonstrating compliance means proving that your product meets the applicable requirements. Depending on the product, this compliance will be assessed by a competent authority, a notified body, or through self-declaration. In all cases, it rests on solid technical documentation that includes the following: product description, identification means for the product, applied standards, test results.

This documentation must be accessible to control authorities and retained over time.

✓ Are you ready? Do you have — or can you quickly produce — technical documentation covering these elements?

Question 6 – How do you prepare for an inspection?

Inspections and controls exist to ensure there is no deception or error likely to create a safety or health risk. Being prepared means being able to quickly present technical documentation, the necessary product traceability, and evidence of adequate quality control.

The good news: a company that has answered positively to the previous questions is already well positioned to face an inspection.

✓ Are you ready? Can you generate this information quickly?

Question 7 – How does regulation affect me at a congress?

This is a question that is often underestimated and yet crucial. The qualification of your product affects what you can say and write: on your stand, in your communication materials, on your website, and even verbally during exchanges with professionals.

You can only claim what is proven and compliant with the applicable regulation. Choosing a “lighter” regulatory status to simplify market access, then making therapeutic claims verbally, carries real regulatory liability.

✓ Are you ready? Can you scientifically and technically substantiate all your claims — written and verbal?

Question 8 – What should I do if my product changes?

Any change — whether it is a product improvement, a supplier change, a new intended use, or an evolution of regulatory requirements — must be subject to an impact analysis. Ignoring this step can call into question the compliance of an already-marketed product.

Regulatory watch is the other side of this question: requirements evolve, and it is the manufacturer’s responsibility to adapt.

✓ Are you ready? Do you routinely carry out change impact analyses and regulatory monitoring?

Question 9 – What should I do if I cannot identify the applicable requirements?

This is a common situation particularly for products in a grey area, such as veterinary medical devices, for which there is no dedicated regulatory authority in France and no harmonised framework at European level. An important point: CE marking for medical use is not valid for a veterinary indication.

In this case, the minimum approach involves demonstrating that attempts were made to identify the applicable regulations, technical documentation showing the product is safe, and evidence of compliance with regulations for specifically regulated products.

✓ Are you ready? If your product is in a grey area, do you have these elements in place?

Question 10 – What should I do if I answered no to most of the questions?

This is not a dead end. The remediation approach involves formalising the situation, identifying what should have been done, assessing the safety impact, and building an action plan to correct and prevent.

The key is to act before being forced to by an inspection, an audit or a complaint. The earlier the process is engaged, the less costly and disruptive it is.

✗ Not ready? Now is the right time to build your action plan.

Conclusion

These 10 questions do not cover the full scope of regulatory challenges. I have designed them to help you quickly assess your compliance level and identify priorities. They apply to any product intended for horses, but more broadly to any animal health product and, to a large extent, to human health products as well.

Regulation is not a constraint to endure. When properly anticipated and managed, it protects your business, gives credibility to your product and opens markets. A One Health Compliance Technical Day allows you to address these questions in a structured format tailored to your situation: in one day, identify the requirements applicable to your product, assess your compliance level and define the next steps — whether you want to develop a veterinary product, consider moving from animal health to human health, or secure the market launch of an existing product.

→ Do you recognise yourself in these questions? Let’s talk for 15 minutes.

References

[1] Pôle Hippolia. #webinaire | Les 10 questions à se poser pour réussir sa stratégie réglementaire. LinkedIn, September 2025. [Online]. Available at: https://www.linkedin.com/ one-health-compliance_webinaire-santeequine-strategie

[2] Dejean S. 10 questions à se poser pour réussir sa stratégie réglementaire. LinkedIn, September 2025. [Online]. Available at: https://www.linkedin.com/posts/sandra-one-health-compliance_webinaire-santeequine-strategie.

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