Medical Devices For Veterinary Use Europe

Medical device shortages during the covid 19 public health emergency.

Medical devices for veterinary use europe.

It requires a veterinary prescription and is one of the oral routes to administer veterinary medicines to animals. Medical devices are products or equipment intended generally for a medical use and are regulated at member state level. As part of their implementation the two regulations require the european commission to adopt delegated and implementing acts. Veterinary medical devices are products which are 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 which is intended to affect the structure or any function of the body of man or other animals.

According to fda definition a device is. Let s start with a comparison of the definition of a medical device by fda and the eu. The danish legislation and eu directives on medical devices only include medical devices for human beings. The eu regulates the manufacture placing on the market and use of medicated feed which is a specific type of feed.

On 26 july 2008 in europe the recast of the medical device directive response from belgium to the public consultation stated we remind that veterinary medical devices also need to be regulated at european level veterinary medical devices are not regulated at eu level. Regulatory information this section of the website provides information on the regulation of medicines for veterinary use in the european union eu. Medical devices for veterinary use are not included in the legislation and therefore there is no requirement that they must be ce marked as medical devices or meet the requirements for the ce marking. This article presents the regulatory framework for veterinary medical devices including examples and related guidelines for manufacturers and distributors within europe and territories in switzerland and the uk.

Cvm is sharing these recall announcements because these devices may be used in veterinary settings. Implementation of regulation eu 2019 6 on veterinary medicinal products and regulation eu 2019 4 on medicated feed. It particularly concerns the centralised procedure where the european medicines agency ema plays a key role. The only exception concerns devices to be evaluated if they form part.

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. Below is a list of the acts the european commission will adopt in the coming years.