Classify equipment, diagnostic tests, software and animal health technology correctly before making performance or compliance claims.
A veterinary device is not automatically a human medical device
The EU Medical Devices Regulation is built around a human medical intended purpose. A product intended exclusively for animals is not brought into that regime simply by being called a medical device. Dual-purpose products and borderline medicines require a specific assessment. Other product rules may still require conformity assessment or CE marking.
Equipment and digital products
We review the intended purpose, users, environment and risks of imaging equipment, monitoring sensors, diagnostic kits and clinical software. Depending on the product, electrical, radio, machinery, chemical, product-safety or data-protection rules may apply. CE marking must be linked to the legislation that actually covers the product.
Contracts, claims and incidents
Technical specifications and advertising should distinguish validated performance from development goals. Supply and maintenance contracts need clear acceptance criteria, calibration duties, updates, training and incident handling. For practice software, access to records, confidentiality, hosting and continuity when a supplier changes are commercially significant.
Example: an AI-assisted diagnostic tool
A supplier offers software that flags abnormalities in animal scans. We examine intended use, promotional claims, the role of the treating veterinarian, data rights and contractual liability. Legal classification is documented before selecting a certification route or making claims that a particular EU medical-device approval is required.
Preparing for advice
Please provide the relevant contracts or official correspondence, a dated account of events and any technical or veterinary reports. Identify the parties, the country or German state involved, and every known deadline. We will agree the appropriate next step after reviewing the documents.
Related services
Legal framework & further reading
Reviewed 8 November 2026. Examples are illustrative and do not describe reported client matters.
Discuss your matter
Send a short description, the parties involved and any deadline. We check conflicts and agree the scope and fees before starting work. For urgent matters, telephone our office as well.
Further practical issues
Intended purpose and product documentation
Define the intended species, user, setting and limits of use. Materials, components, instructions and promotional claims should tell a consistent story. Sterile products, invasive applications and reusable equipment can raise different questions. A change to the intended application or software should prompt a fresh assessment rather than be treated as an editorial update.
Purchasing, leasing and maintaining clinical equipment
Equipment contracts should address the specification, acceptance, installation, training, maintenance and support required by the practice. Clarify spare parts, repair times, software updates and the consequences of downtime. An equipment defect and a later treatment interruption may involve different claims and different evidence.
Software, data and connected diagnostics
Determine whether the software merely displays information, supports an assessment or controls a device. The description of its actual functions matters more than a general label such as assistance software. Contracts should allocate access, updates, support and responsibilities. Owner, employee or customer information may also require a separate data-protection assessment.
Distinguish product damage from clinical use
After an incident, retain the device identification, purchase and service records, instructions, logs and relevant treatment documentation. A product defect, deficient instructions, a maintenance issue and an application error should not be conflated. We assess contractual remedies, liability allegations, insurance and any related authority procedure alongside the technical investigation.