Medical Devices For Veterinary Use Europe

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.

Medical devices for veterinary use europe.

As part of their implementation the two regulations require the european commission to adopt delegated and implementing acts. 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. It is a follow up to us and eu veterinary medical device regulation 1 introduction. 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.

The danish legislation and eu directives on medical devices only include medical devices for human beings. Depending on specific situation this can be the most effective way to administer veterinary medicines to animals. Medical device shortages during the covid 19 public health emergency. It particularly concerns the centralised procedure where the european medicines agency ema plays a key role.

The eu regulates the manufacture placing on the market and use of medicated feed which is a specific type of feed. Below is a list of the acts the european commission will adopt in the coming years. According to fda definition a device is. Implementation of regulation eu 2019 6 on veterinary medicinal products and regulation eu 2019 4 on medicated feed.

The only exception concerns devices to be evaluated if they form part. Regulatory information this section of the website provides information on the regulation of medicines for veterinary use in the european union eu. 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. 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.

Cvm is sharing these recall announcements because these devices may be used in veterinary settings. 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.