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.

The eu regulates the manufacture placing on the market and use of medicated feed which is a specific type of feed. According to fda definition a device is. 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 particularly concerns the centralised procedure where the european medicines agency ema plays a key role.

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. The danish legislation and eu directives on medical devices only include medical devices for human beings. Cvm is sharing these recall announcements because these devices may be used in veterinary settings. 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.

As part of their implementation the two regulations require the european commission to adopt delegated and implementing acts. It requires a veterinary prescription and is one of the oral routes to administer veterinary medicines to animals. The only exception concerns devices to be evaluated if they form part. Medical device shortages during the covid 19 public health emergency.

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. Implementation of regulation eu 2019 6 on veterinary medicinal products and regulation eu 2019 4 on medicated feed. 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. It is a follow up to us and eu veterinary medical device regulation 1 introduction.

Regulatory information this section of the website provides information on the regulation of medicines for veterinary use in the european union eu. Below is a list of the acts the european commission will adopt in the coming years.