J 2020

Note on the regulation of veterinary medical devices in the EU: A review of the current situation and its impact on animal health and safety

POTOČKOVÁ, Hana, P. KUSNIERIK and Jiří DOHNAL

Basic information

Original name

Note on the regulation of veterinary medical devices in the EU: A review of the current situation and its impact on animal health and safety

Authors

POTOČKOVÁ, Hana (203 Czech Republic, guarantor, belonging to the institution), P. KUSNIERIK and Jiří DOHNAL (203 Czech Republic, belonging to the institution)

Edition

ANIMAL WELFARE, WHEATHAMPSTEAD, UNIV FEDERATION ANIMAL WELFARE, 2020, 0962-7286

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30104 Pharmacology and pharmacy

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

Impact factor

Impact factor: 2.244

RIV identification code

RIV/00216224:14160/20:00118085

Organization unit

Faculty of Pharmacy

DOI

UT WoS

000518404800004

Keywords in English

animal welfare; efficacy; European Union; regulation; safety; veterinary medical devices

Tags

Tags

International impact, Reviewed
Změněno: 24/2/2021 13:10, Mgr. Hana Hurtová

Abstract

V originále

Medical devices form a large heterogeneous group of products ranging from simple tools to medical testing and implants, the safety and efficacy of which are strictly regulated in all developed countries. Thanks to the health and cost benefits, medical devices have also found their way into veterinary medicine but, surprisingly, the regulation of these products is far less complex or, in some cases, missing altogether. Given the complexity and potential hazards of certain veterinary devices, the current state of affairs may lead to health and safety risks, both for animals and personnel involved. This review is the first to systematically map the current situation in the EU, revealing health and safety risks in practice for both animals and personnel involved and discussing them in a broader context. Only six out of the EU's 28 member states (Belgium, Croatia, Czech Republic, Germany, Hungary, and Slovakia) were found to have at least a degree of regulation of veterinary devices. As a result, a single product may be regulated as a veterinary medicinal product, a veterinary medical device or not be regulated at all, depending on the particular EU member state in question. As things stand, veterinary medicine makes use of all kinds of medical devices, including human products, regardless of their regulatory status and (pre-market) control. However, the use of such devices may influence the health and well-being of animals. Several measures are therefore suggested to attain the required levels of safety and efficacy surveillance for veterinary medical devices without creating excessive administration.