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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

Published online by Cambridge University Press:  01 January 2023

H Potockova ,
P Kusnierik  and
J Dohnal
H Potockova*
Affiliation:
Bioinova, s.r.o., Vídeňská 1083, 14200 Prague, Czech Republic Department of Applied Pharmacy, Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno, Palackého 1, 612 42 Brno, Czech Republic
P Kusnierik
Affiliation:
Contipro a.s., Dolní Dobrouč 401, 56102, Dolní Dobrouč, Czech Republic
J Dohnal
Affiliation:
Department of Applied Pharmacy, Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno, Palackého 1, 612 42 Brno, Czech Republic
*
* Contact for correspondence: Hana.potockova@bioinova.cz
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Abstract

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.

Keywords

animal welfareefficacyEuropean Unionregulationsafetyveterinary medical devices
Type
Research Article
Information
Animal Welfare , Volume 29 , Issue 1 , February 2020 , pp. 37 - 43
Copyright
© 2020 Universities Federation for Animal Welfare

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References

American Association of Equine Practitioners 2010 Medical devices – A white paper on medical devices in equine medicine. American Association of Equine Practitioners: Lexington, KY, USAGoogle Scholar
Bertani, F 2017 Italian survey about regulations on veterinary medical devices and in vitro diagnostic tests at EU level. Heads of Medicines Agencies Meeting. 23-24 February 2017, Valletta, MaltaGoogle Scholar
Central Drugs Standard Control Organisation 2013 Frequently asked questions on registration and import of medical devices in India. Government of India: Delhi, IndiaGoogle Scholar
Cunningham, J, Dolan, B, Kelly, D and Young, C 2015 Medical device sectoral overview. Whitaker Institute for Innovation & Societal Change: Galway, Republic of IrelandGoogle Scholar
De Briyne, N, Gopal, R, Diesel, G, Iatridou, D and O’Rourke, D 2017 Veterinary pharmacovigilance in Europe: a survey of vet-erinary practitioners. Veterinary Record Open 4(1): e000224. https://doi.org/10.1136/vetreco-2017-000224CrossRefGoogle Scholar
Dunn, ME and Berent, AC 2017 Urologic interventional thera-pies. In: Ettinger, SJ, Feldman, EC and Cote, E (eds) Textbook of Veterinary Internal Medicine: Disease of the Dog and the Cat pp 825–855. Elsevier: St Louis, MO, USAGoogle Scholar
European Commission 2010 Medical devices: Guidance docu-ment — Classification of medical devices (MEDDEV 2.4/1 Rev 9). EC: Brussels, BelgiumGoogle Scholar
European Commission 2017 Manual on borderline and classification in the community regulatory framework for medical devices (Version 1.18.). EC: Brussels, BelgiumGoogle Scholar
European Medicines Agency 2010 CVMP analysis of the functioning of current veterinary legislation and proposals for its evolution and comments on the Commission papers (EMA/CVMP/463298/2010). European Medicines Agency: London, UKGoogle Scholar
French-Mowat, E and Burnett, J 2012 How are medical devices regulated in the European Union? Journal of the Royal Society of Medicine 105: S22–S28. https://doi.org/10.1258/jrsm.2012.120036CrossRefGoogle ScholarPubMed
Gauvin, J 2015 Trends in veterinary medicine in Canada. Canadian Veterinary Journal 56: 219–222Google ScholarPubMed
George, B 2010 Registration of medical devices. Perspectives in Clinical Research 1: 90–93Google ScholarPubMed
Government of Japan 2012 EU-Japan Business round table. Report from the Government of Japan concerning the recommendations from the EU-Japan Business round table. 14th EU-Japan Business Round Table, Tokyo, JapanGoogle Scholar
Heneghan, C and Thompson, M 2012 Rethinking medical device regulation. Journal of the Royal Society of Medicine 105: 186–188. https://doi.org/10.1258/jrsm.2012.12k030CrossRefGoogle ScholarPubMed
Hunault, JL 2017 Proposed regulation on in vitro diagnostic medical devices. Request for introduction of an amendment for veterinary in vitro Proposed regulation on in vitro diagnostic medical devices. Request for introduction of an amendment for veterinary in vitro Diagnostics for Animals: Paris, FranceGoogle Scholar
Kesic, D 2011 Pharmaceutical industry in strategic development. International Journal of Economic Research 2(6): 29–37Google Scholar
LEK Consulting Ltd 2013 Expanding in China's medtech market: Navigating market access and tendering. LEK Consulting Ltd: Shanghai, ChinaGoogle Scholar
Li, TW, Tu, PW, Liu, LL and Wu, SI 2015 Assurance of med-ical device quality with quality management system: An analysis of good manufacturing practice implementation in Taiwan. Biomed Research International: 6700420. https://doi.org/10.1155/2015/670420CrossRefGoogle Scholar
Meticulous Research Pvt Ltd 2016 Global Veterinary/Animal Equipment Market Outlook: 2016–2021. Meticulous Research Pvt Ltd: Pune, IndiaGoogle Scholar
Migliore, A 2017 On the new regulation of medical devices in Europe. Expert Review of Medical Devices 14: 921–923. https://doi.org/10.1080/17434440.2017.1407648CrossRefGoogle ScholarPubMed
Ministry of Agriculture 2015 Registration of veterinary medical devices. http://english.agri.gov.cn/mfv/201509/t20150930_26599.htmGoogle Scholar
Mongolian State 2010 Law of Mongolia on medicines and medical devices (revised version). Mongolian State: Ulaanbaatar, MongoliaGoogle Scholar
Rosenheck, S, Davis, G, Sammarco, CD and Bastian, R 2017 Effect of variations in stent placement on outcome of endolumi-nal stenting for canine tracheal collapse. Journal of the American Animal Hospital Association 53: 150–158. https://doi.org/10.5326/JAAHA-MS-6485CrossRefGoogle ScholarPubMed
Roser, B and Warner, J 2014 Safeguarding animal health and welfare. Regulatory Rappourteur 11: 3Google Scholar
Szkotnicki, J 2014 Canadian Animal Health Sector: An overview of challenges and opportunities. International Animal Health Journal 2: 10–15Google Scholar
Tamura, A and Hiromu, K 2014 Multiregional medical device devel-opment: regulatory perspective. Clinical Journal of Gastroenterology 7:108–116. https://doi.org/10.1007/s12328-014-0478-2CrossRefGoogle Scholar
Thome-Kromer, B 2015 Konsequenzen des Wechsels der vorgesehe-nen Anwendung von Medizinprodukten und i n vitro Diagnostika vom Mensch zum Tier in Deutschland/Europa. PhD Thesis, Rheinischen Friedrich-Wilhelms Universität Bonn, Bonn, Germany. [Title trans-lation: Consequences of the switch of the intended use of medical devices from human to veterinary use in Germany/Europe]Google Scholar
Thornton, PK 2010 Livestock production: recent trends., future prospects. Philosophical Transactions of the Royal Society of London 365: 2853–2863. https://doi.org/10.1098/rstb.2010.0134CrossRefGoogle ScholarPubMed
van Drongelen, A, Hessles, J and Geertsma, R 2015 Comparison of market authorisation systems of medical devices in USA and Europe. The Dutch National Institute for Public Health and the Environment: Bilthoven, The NetherlandsGoogle Scholar
Voerhoeven, N and Hierner, E 2008 High-pressure injection injury of the hand: an often-underestimated trauma: case report with study of the literature. Strategies in Trauma and Limb Reconstruction 3(1): 17–33. https://doi.org/10.1007/s11751-008-0029-9CrossRefGoogle Scholar
World Health Organisation 2017 Global Atlas of Medical Devices. WHO Document Production Services: Geneva, SwitzerlandGoogle Scholar
Yahiro, MA and Nakai, K 2004 Japan's New Regulatory System. https://www.mddionline.com/japans-new-regulatory-systemGoogle Scholar
Yuwadee, P 2013 Thailand: regulatory and medical device con-trol In: Wong, J and Kaiyu, RT (eds) Handbook of Medical Device Regulatory Affairs in Asia p 528 CRC Press: Boca Raton, FL, USA. https://doi.org/10.1201/b14081-43CrossRefGoogle Scholar