Veterinary Medical Devices Regulation in EU & FDA

Veterinary medical devices regulation is a seldomly discussed topic and therefore BioReg Services have decided to share with you our knowledge and experience within the EU regulatory framework and veterinary medical device market.

Let’s start with a comparison of the definition of a medical device by FDA and the EU.

According to FDA definition, a device is:

“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Is FDA premarket approval for veterinary medical devices required?

In contrast to human medical device products, FDA does not require submission of a 510(k), PMA, or any pre-market approval for devices used in veterinary medicine.

Veterinary medical device companies that manufacture radiation emitting devices need to register their products under the radiological health regulations, administered by the Center for Devices Radiological Health (CDRH).

Device manufacturers who exclusively manufacture or distribute veterinary devices are not required to register their establishments and list veterinary devices and are exempt from post-marketing reporting.

However, FDA does have regulatory oversight over veterinary devices and can take appropriate regulatory action if a veterinary device is misbranded or adulterated.

It is the responsibility of the manufacturer and/or distributor of veterinary (animal) devices to assure that these products are safe, effective, and properly labeled.

FDA recommends that manufacturers and/or distributors of veterinary medical devices request a review of their product labeling and promotional literature to ensure that it complies with the Act. This includes devices marketed in another country and offered for importation into the U.S.

According to EU (MDD) medical device definition, a medical device is:

any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
investigation, replacement or modification of the anatomy or of a physiological process,
control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;”

Although an EU medical device definition does not specifically mention “animals”, veterinary medical devices in EU need to demonstrate that they fall under this definition in order to be excluded from medicinal (drug) product requirements.

What is an animal in the eyes of veterinary device regulation?

As we all know, there is still no regulatory definition as to what a human being is which would, I think we can all agree, be a considerably serious undertaking. However, we were very surprised to discover that regulators do have a definition as to what an animal is:

Mammals (other than humans), birds, fish, reptiles, molluscs, crustaceans, honey bees and any other animal kept for human consumption or any of whose produce is intended for human consumption and a domestic animal, a wild animal, in captivity and any other wild animal [Animal Remedies Act, 1993, S.I. No. 23 of 1993, Animal Remedies Act (Section 2) Order 2005, S.I. No. 733 of 2005, HPRA, Ireland].

Is Your Veterinary Product a Medical Device?

In accordance with the definition of a medical device, the first step would be to ensure that the product does not achieve its principal intended action by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Besides assessing the principal intended action (primary mode of action), a regulatory agency will usually evaluate other characteristics of the products to decide whether it is veterinary medicine or a medical device for animals. For example, if the product is labelled for prescription use and the indications for use include serious medical conditions, the regulators may be inclined to define such a product as a veterinary medicine.

Some regulatory agencies will define a medicinal product as any product containing a substance with a pharmacological effect on physiological function at the dosage used, irrespective of the presence or absence of claims in the product packaging or literature.

Once you have established that the product is indeed a medical device, and the regulatory agency concurs with your opinion, the road to the EU market is almost straightforward assuming the product is safe and properly labelled.

Veterinary Medical Devices Labelling

As with any other healthcare product, a veterinary medical device should be properly labelled. The product labelling, including the package leaflet, for veterinary products are necessary and should include at the very least:

Name of an approval holder and the name of a manufacturer where these differ
Trade name of the product
Target species
Fill volume/weight of the container /length
Qualitative composition (may be completed with analytical composition)
Intended use of the product (short description of the product, aim of its use)
Information on a method of administration and dosing
Precautions necessary for the safe use of the product
Shelf-life of the product as packaged for sale, shelf-life after first opening
Batch number or date of manufacture
Special precautions for storage of the product
Special precautions for the disposal of unused product or waste materials derived from the use of such product
Approval number of the product or internal company catalogue number
Wording “Veterinary product” and “For animals only”

Please note that this list may not be exhaustive.

Selected EU countries and Veterinary Medical Devices Regulations

In the following sections we hope to provide useful and up to date information as to how different EU countries regulate veterinary medical devices products.

Denmark

In Denmark, a company is not required to register with the Danish Medicines Agency in order to market veterinary medical devices. Additional information can be found on the following websites:

Germany

Assuming a medicinal device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, it will not be regulated by BVL which is responsible for the national and European authorisation of veterinary drugs in Germany (check out more about that here).

Provided that the product in question cannot be classified as a Veterinary Medicinal Product (VMP) by presentation or function, then BVL registration is not required.

In Germany, the qualification or definition as a veterinary medical device has no legal relevance since veterinary medical devices are not specifically regulated.

Nevertheless, these products do have to meet the general regulations for all products on the market, e.g. the requirements of animal welfare according to the German Protection of Animals Act and requirements of the Product Safety Act (check out more about thate here)

If the product contains any substance which may cause potentially harmful side-effects on or in the animal, the demonstration of their absence will have to made available to the competent authority upon request.

Belgium

Medical devices with CE marking can be used by vets in Belgium without any further notification. If the company would like to “register” the medical device in Belgium before CE marking is obtained, it has to apply for a veterinary medical device at the Federal Agency for Medicines and Health Products (FAMHP). Please note that this legislation will change in the near future whereby such registration will no longer be necessary and these products will be granted free marketing status.

Czech Republic

According to Act No 166/1999 regarding veterinary care, a person who markets a veterinary device is obliged to notify basic data for this device to the Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM) before its introduction to the market. Following this notification, the veterinary medical device will be registered in the list of veterinary medical devices.

As well as the veterinary device pathway, ISCVBM have introduced an additional regulatory pathway for “non-medicinal veterinary products”.

Approval of non-medicinal veterinary products which do not fall within the scope of a medicinal product definition (dietetics, vitamins, mineral and cosmetic products and diagnostics) is subject to this simplified authorisation procedure.

In order to decide whether your product is eligible for the simplified authorisation procedure, the Marketing Authorizations and Approvals Department (Institute for State Control of Veterinary Biologicals and Medicines) will require the proposed text for the product labelling and/or package leaflet.

Slovenia

Medical devices for veterinary use are not regulated by national law and, in order to be marketed, such devices must hold a CE certificate.

Ireland

The Irish Health Products Regulatory Authority (HPRA) provides a classification enquiry procedure for products to determine if they require a veterinary authorisation (i.e. whether a product is classed as a veterinary medicinal product) or if the products can be authorised outside of the Animal Remedies Regulations.

Readers are advised to refer to a very informative document, “Guide to the definition of an animal remedy and the classification process” which is available through the HPRA website.

Besides the basic prerequisite of not falling into medicinal product definition, these products also have to fulfil the following conditions:

no medicinal claims are made on the product literature
the product does not contain pharmacologically active substances
the product is used as intended

The guidance document includes a long list of product types, including medical devices as defined by Council Directive 93/42/EEC. In order to enquire whether a specific product qualifies for this category, the applicant should complete an application form for a classification request. A separate form is required for each application along with the labelling and promotional literature for each product.

Bulgaria

At the moment, there is no legislation regarding veterinary medical devices and therefore companies can freely trade such products providing they do not claim a curative or prophylactic effect in animals.

How can BioReg help you to regulate your veterinary medical devices

BioReg Services can help you in multiple ways to enable your veterinary medical device reach the EU market.

Among other services we can:

Advice whether your veterinary product would be defined as a medical device
Advise how to best present your product and to qualify for medical device category
Review and upgrade your product labelling and promotional material
Review your veterinary company website to comply with the applicable regulations
Compile a product application file
Guide you through the registration process to reach the market in the shortest time
Serve as your liaison with the EU national regulatory authorities
Help you to define whether the object of your product is a “regulated animal” or just an old-fashioned but beautiful – animal…

BioRegards,

Daniel