Yes, veterinary devices are covered by EU MDR 2017/745, but the rules depend on what the device does and where it is used

The EU Medical Device Regulation 2017/745 (MDR) applies to devices intended for use in animals, not just humans. However, not every tool or product a veterinarian uses falls under it. The regulation covers devices designed to diagnose, prevent, monitor, or treat disease in animals — but only if they meet the definition of a medical device under the regulation. A stethoscope, thermometer, or ultrasound machine used on animals counts. A feeding bowl or cage does not.

The key question is whether the device is intended to have a medical function. If a product is marketed or designed to work on an animal's body to achieve a medical outcome, it is likely covered. If it is a general-purpose tool or piece of equipment, it probably is not. The classification also depends on the risk level: a straightforward thermometer is lower risk than a surgical implant, so it faces fewer regulatory requirements.

Key Takeaways

  • EU MDR 2017/745 covers veterinary devices that diagnose, prevent, monitor, or treat animal disease, but only if they are designed or marketed for that medical purpose.
  • Devices are classified into four risk categories — Class I, IIa, IIb, and III — and higher-risk devices require more documentation, testing, and approval before they can be sold.
  • Veterinary devices must carry a CE mark and comply with the same technical and safety standards as human medical devices, though some rules are tailored for animal use.
  • Manufacturers must register with a notified body for higher-risk devices and keep detailed records of safety and performance data throughout the device's lifetime.
  • Devices already on the market under the old Medical Device Directive (93/42/EEC) had until May 2024 to transition to MDR compliance, though some extensions have been granted.

What counts as a veterinary device under MDR 2017/745

A veterinary device under MDR 2017/745 is any instrument, apparatus, implant, reagent, software, or other article intended by the manufacturer to be used on animals to diagnose, prevent, monitor, treat, or alleviate disease or injury. The regulation does not distinguish between companion animals, livestock, or wildlife — the same rules explore across all animal types.

Examples of devices covered include diagnostic ultrasound machines, surgical instruments designed for animal use, dental equipment for animals, orthopedic implants, wound dressings marketed for veterinary use, and diagnostic test kits for animal diseases. Software that controls or monitors a device also counts as part of the device itself.

Products that are not covered include general-purpose items like cages, bedding, or feeding equipment, even if used in a veterinary setting. Medicines and vaccines are regulated separately under pharmaceutical law, not the MDR. General-purpose tools like scissors or forceps that are not specifically designed or marketed for medical use on animals also fall outside the scope.

How veterinary devices are classified by risk level

The MDR sorts all medical devices into four classes based on the risk they pose. Veterinary devices follow the same classification rules as human devices, though some criteria are adapted for animal anatomy and use.

Class I devices carry the lowest risk and include straightforward items like thermometers, stethoscopes, and basic wound dressings. They require a CE mark and compliance with general safety standards, but do not need approval from a notified body before sale.

Class IIa devices are moderate-risk items such as diagnostic imaging equipment, infusion pumps, and some surgical instruments. They require technical documentation, a quality management system, and review by a notified body before they can be marketed.

Class IIb devices carry higher risk and include implants, active devices that deliver energy (like surgical lasers), and some diagnostic equipment. They require more extensive clinical data, a notified body review, and ongoing post-market surveillance.

Class III devices are the highest-risk category and include implants that support or sustain life, devices that deliver drugs or biological substances, and some advanced diagnostic tools. They require the most rigorous testing, clinical evidence, and notified body approval before any sale can occur.

CE marking and technical documentation requirements

All veterinary devices covered by MDR 2017/745 must carry a CE mark before they can be sold in the EU. The CE mark signals that the device meets the regulation's essential requirements for safety and performance. However, the process to earn that mark varies by device class.

For Class I devices, the manufacturer must prepare a technical file that documents the device design, materials, manufacturing process, and how it meets the essential requirements. No notified body review is needed, but the file must be kept available for inspection by competent authorities.

For Class IIa, IIb, and III devices, a notified body — an organization accredited by the EU to assess medical devices — must review the technical documentation and often conduct or review clinical data before the CE mark can be applied. The manufacturer must also establish a quality management system that covers design, manufacturing, storage, and distribution.

Technical documentation must include device specifications, manufacturing details, risk analysis, biocompatibility data (if the device contacts animal tissue), sterilization validation (if applicable), and instructions for use. For higher-risk devices, clinical data from testing on animals or from published literature may also be required.

Post-market surveillance and safety reporting

After a veterinary device is on the market, the manufacturer must monitor its safety and performance through a process called post-market surveillance. This means collecting data on how the device actually performs in veterinary clinics and practices, not just in laboratory testing.

Manufacturers must report serious adverse events — injuries, deaths, or device failures that harm an animal or create a safety risk — to the competent authority in the country where the incident occurred, usually within 30 days. They must also keep records of complaints and investigate them to determine whether the device caused the problem.

Veterinarians and veterinary clinics are expected to report adverse events to the manufacturer or to the national competent authority if they suspect a device has caused harm. The manufacturer must then assess whether the device needs to be recalled, relabeled, or modified to address the safety issue.

Transition from the old Medical Device Directive to MDR 2017/745

The MDR replaced the older Medical Device Directive 93/42/EEC on May 26, 2021. Devices that were legally on the market under the old directive were given a transition period to comply with the new rules. For most devices, that important date was May 26, 2024.

However, the European Commission has granted extensions for certain device categories due to supply chain challenges and the complexity of the transition. Some Class III devices and certain in vitro diagnostic devices received extensions until May 2025 or later. Manufacturers should check the official EU NANDO (New Approach Notified and Designated Organisations) database to confirm the current important date for their specific device.

Devices that do not meet the MDR requirements by the important date cannot legally be sold in the EU, even if they were compliant under the old directive. Veterinary practices should verify that any new devices they purchase carry a valid CE mark under MDR 2017/745, not just the old directive.

Who enforces MDR 2017/745 for veterinary devices

Each EU member state has a competent authority responsible for enforcing the MDR within its borders. In most countries, this is a national health or medicines agency. These authorities inspect manufacturers, review technical files, investigate adverse events, and can order recalls or market withdrawals if a device is unsafe.

Notified bodies are private organizations accredited by national authorities to assess devices on their behalf. They review technical documentation, conduct audits of manufacturing facilities, and issue CE mark approvals for higher-risk devices. A manufacturer can choose which notified body to work with, as long as it is accredited for the device category in question.

Veterinary practices themselves are not responsible for enforcing the MDR, but they are expected to use only devices that carry a valid CE mark and to report any safety concerns to the manufacturer or competent authority. If a practice suspects a device is unsafe or non-compliant, it can report this to the national competent authority.

Frequently Asked Questions

Does MDR 2017/745 explore to devices used outside the EU?

The MDR applies only to devices sold or used within the EU and European Economic Area (EEA). Devices used in countries outside the EU are subject to that country's own regulations. However, a manufacturer that sells the same device in both the EU and other regions must may support it meets the MDR requirements for the EU market.

Are surgical instruments used by veterinarians always covered by the MDR?

Surgical instruments designed and marketed specifically for veterinary use are covered. However, general-purpose surgical instruments (like scissors or forceps) that are not marketed for medical use may not be. The key is whether the manufacturer intends the instrument to diagnose, prevent, monitor, or treat animal disease. If it is sold as a general tool, it may fall outside the MDR.

What happens if a veterinary device does not have a CE mark?

A device without a valid CE mark cannot legally be sold or used in the EU. If a veterinary practice discovers it is using a non-compliant device, it should stop using it and report the issue to the manufacturer or the national competent authority. The practice should also notify the animal owner if the device may have affected the quality of care.

Do veterinary devices need different testing than human medical devices?

Veterinary devices follow the same technical and safety standards as human devices under the MDR. However, clinical testing may differ — for example, a device may be tested on the animal species it is intended for rather than on humans. Biocompatibility and sterilization requirements are the same, but the specific animal anatomy and physiology may affect how the device is designed and validated.

Where can I learn about a specific veterinary device is MDR-compliant?

The EU EUDAMED database (European Database on Medical Devices) is the official registry of devices with valid CE marks under the MDR. You can search by device name, manufacturer, or notified body to confirm a device is compliant. The database became fully operational in 2023 and is publicly searchable.