Medical Devices For Veterinary Use Europe

Let s start with a comparison of the definition of a medical device by fda and the eu.

Medical devices for veterinary use europe.

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. 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. According to fda definition a device is.

It is a follow up to us and eu veterinary medical device regulation 1 introduction. 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. 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.

Medical devices are products or equipment intended generally for a medical use and are regulated at member state level. 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. Depending on specific situation this can be the most effective way to administer veterinary medicines to animals. 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.

Cvm is sharing these recall announcements because these devices may be used in veterinary settings. The medical devices and the in vitro diagnostic devices regulations have introduced new responsibilities for the european medicines agency ema and national competent authorities in the assessment of certain categories of medical device. It requires a veterinary prescription and is one of the oral routes to administer veterinary medicines to animals. 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.

The only exception concerns devices to be evaluated if they form part. As part of their implementation the two regulations require the european commission to adopt delegated and implementing acts.