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Regulation of veterinary point-of-care testing in the European Union, the United States of America and Japan

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Abstract

Point-of-care testing (POCT) is used to detect diseases and other conditions or to monitor therapeutic procedures. In veterinary medicine, POCT not only helps during the prevention, diagnosis and treatment of animal diseases but it also has a direct impact on human health by safeguarding food supplies and preventing zoonoses. Despite its importance, the regulation of the quality, safety and effectiveness of POCT products is rarely discussed. This review reveals that the level of regulatory surveillance of veterinary POCT products in the European Union (EU), the United States of America (USA) and Japan is strikingly different, ranging from no regulation (EU) to comprehensive regulation which is comparable to the procedures for the regulation of human in vitro medical devices (Japan). Details about the licensing procedures in these three locations, discussion of their strengths and weaknesses, and suggestions for possible future development of the regulation of these products are also provided
Rev. Sci. Tech. Off. Int. Epiz., 2021, 39 (3), ... – ...
No. 26082021-00184-EN 1/23
Regulation of veterinary point-of-care
testing in the European Union, the United
States of America and Japan
This paper (No. 26082021-00184-EN) has been peer-reviewed, accepted, edited, and
corrected by authors. It has not yet been formatted for printing. It will be published in issue
39 (3) of the Scientific and Technical Review, in 2021.
H. Potockova (1, 2)*, J. Dohnal (1) & B. Thome-Kromer (3)
(1) Department of Applied Pharmacy, Masaryk University,
Palackého tř. 1946/1, Brno 612 00, Czech Republic
(2) Bioinova, s.r.o., Vídeňská 1083, Prague 142 00, Czech Republic
(3) Regulatory and Quality Management, Strasse der Jugend 32,
D-14532 Kleinmachnow, Germany
*Corresponding author: hana.potockova@bioinova.cz
Summary
Point-of-care testing (POCT) is used to detect diseases and other
conditions or to monitor therapeutic procedures. In veterinary
medicine, POCT not only helps during the prevention, diagnosis and
treatment of animal diseases but it also has a direct impact on human
health by safeguarding food supplies and preventing zoonoses.
Despite its importance, the regulation of the quality, safety and
effectiveness of POCT products is rarely discussed. This review
reveals that the level of regulatory surveillance of veterinary POCT
products in the European Union (EU), the United States of America
(USA) and Japan is strikingly different, ranging from no regulation
(EU) to comprehensive regulation which is comparable to the
procedures for the regulation of human in vitro medical devices
(Japan). Details about the licensing procedures in these three
locations, discussion of their strengths and weaknesses, and
suggestions for possible future development of the regulation of these
products are also provided.
Rev. Sci. Tech. Off. Int. Epiz., 39 (3) 2
2/23
Keywords
European Union – Japan – Point-of-care testing – Regulation – United
States of America Veterinary diagnostics.
Introduction
Point-of-care testing (POCT), based on the in vitro analysis of
biological specimens, is routinely used to detect diseases, monitor
therapeutic procedures and provide prognosis (1). This broad term
encompasses the use of diagnostic products ranging from simple non-
active consumables (e.g. lateral flow tests) to sophisticated benchtop
instruments (e.g. haematology analysers). In small animal practices,
POCT provides data for immediate medical decisions to improve
patient outcome, increase owner satisfaction and also maximise clinic
profitability (2). In livestock management, POCT analysis (of milk
etc.) is often used in line with the principles of precision farming to
control health and welfare of the animals effectively or to facilitate
breeding by detecting oestrous cycle, pregnancy or fertility
problems (3, 4).
Veterinary POCT may also directly influence human health by
safeguarding food supplies and enabling timely detection, prevention
and control of zoonoses outbreaks. In fact, the majority of emerging
human pathogens are zoonotic in origin (5) and their uncontrolled
spread may have devastating impacts on global health and economy,
as seen recently during the severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) epidemic (6). In this scenario, the role
of veterinary POCT is not in the identification of new zoonotic
diseases but in the early detection of already known infectious agents.
Veterinary POCT can also be used for first-line testing of biological
samples from livestock and wildlife before their transfer to centralised
laboratory facilities (7). The effectiveness of this approach was well
illustrated during the latter stages of the Global Rinderpest Eradication
Programme (GREP). Additionally, such decentralised POCT can
decrease economic losses by reducing the unnecessary slaughter of
uninfected animals in situations where rapid action is needed to
prevent the spread of disease (8, 9).
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To ensure the above-mentioned functions, the data gained by POCT
must be sufficiently reliable (10). Each POCT product has its
limitations in terms of sensitivity and specificity but these limitations
must be duly determined by the manufacturer and must correspond to
the intended use of the product. There are several global guidelines
available addressing the quality of veterinary diagnostics. First,
veterinary laboratories can implement International Organization for
Standardization (ISO)/International Electrotechnical Commission
(IEC) 17025, which specifies general requirements for the
competence, impartiality and consistent operation of analytical
laboratories. Second, the World Organisation for Animal Health
(OIE), an intergovernmental organisation with 182 Members, has
developed two approaches to facilitate the regulation of veterinary
diagnostics. Most importantly, it publishes the Manual of Diagnostic
Tests and Vaccines for Terrestrial Animals (Terrestrial Manual) and
the Manual of Diagnostic Tests for Aquatic Animals (Aquatic Manual)
which provide internationally agreed standards, guidelines and
recommendations for the use of diagnostic laboratory methods and
veterinary diagnostic kits analysing samples from terrestrial and
aquatic animals, respectively (11, 12). Additionally, the OIE maintains
a register of diagnostic kits with validated fitness for purpose’,
i.e. kits with proven performance (13). Fourteen kits are currently
registered but nearly all of them have been designed for laboratory
use. Specific guidelines for POCT would be beneficial to support the
decentralised use of these rapid tests and methods by laypersons and
untrained veterinary professionals in an uncontrolled environment
(farms, households and small animal practices).
In human medicine, products used for POCT are regarded as in vitro
diagnostic (IVD) medical devices. These devices are subject to
comprehensive regulation in all developed countries such as the
European Union (EU), the United States of America (USA), Japan,
Australia and Canada (14) and some form of regulatory oversight is
applied in most countries worldwide (15). The degree of regulation
varies greatly among the different locations and depending on the risk
class of the product (14, 16). Regulations typically apply to the entire
product’s lifecycle to ensure its quality. They affect development
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(e.g. design, transfer to production), pre-market (e.g. labelling,
advertisement) and post-market (e.g. vigilance, post-market
surveillance, disposal) activities. Given that the variety and
complexity of regulatory processes may limit the availability of
products on the market, several organisations such as the World
Health Organization (WHO) and the International Medical Device
Regulators Forum (IMDRF) strive for their international
harmonisation (13, 17).
Despite equivalent roles of human and veterinary POCT products, the
regulatory status of the latter is far less clear and rarely discussed. The
relevant sources are scarce and, if available, they focus on the
international harmonisation and licensing procedures of laboratory
diagnostic methods rather than on POCT (10). Yet these products are
widely available to end-users such as farmers, veterinarians and
animal owners, and are therefore increasingly important in current
veterinary practice.
This article aims to provide an insight into the regulation of these
POCT products in the EU, the USA and Japan. These three locations
are among the founding members of relevant international regulatory
groups such as the Veterinary International Conference on
Harmonization (VICH) (18) and the IMDRF (19). As such, they
significantly influence global regulation and present a role model for
other states. The USA, the EU and Japan are also the biggest
producers of medical devices, together accounting for more than 85%
of the world’s market (20). The quality of their products directly
influences users all over the world. The presented comparison should
not only provide useful information for veterinarians, animal owners,
manufacturers and policymakers but also initiate discussion about the
regulation of these products.
European Union
Currently, there is no harmonised EU legislation on veterinary POCT
products (21). However, in common with all products marketed in the
EU and not regulated by dedicated legal acts, veterinary POCT
products must comply with Directive 85/374/EEC on product liability
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and Directive 2001/95/EC on general product safety. In addition,
POCT products using electrical energy (e.g. blood chemistry
analysers) are further subject to Directive 2014/30/EU on
electromagnetic compatibility and Directive 2014/35/EU for low
voltage instruments. Given that none of these directives has been
designed to evaluate the specific properties of veterinary POCT
products, some EU member states have adopted national laws to
ensure their safety and performance while others (e.g. Belgium and
Italy) have no specialised rules that cover these products. This lack of
a harmonised approach leads to different scopes of regulation and
unequal legal requirements among EU member states and creates
barriers within the single market. More details of national approaches
are outlined below.
Veterinary POCT kits (sets of reagents) are subject to national
regulation in several EU countries. The subject of these regulations
may be further specified as intended to test tissues and body liquids of
food-producing animals (Bulgaria) (22), manufactured from or with
the aid of microorganisms or parasites (the Netherlands) (23), used for
serological diagnosis of animal diseases (Romania) (24) or designed
to detect infectious diseases, biological impurities and residues of
prohibited substances in animal tissues and animal products
(Poland) (25). Each country then applies its national legislation to
grant marketing approval. The marketing applications include
administrative data, product description, summary of analytical
performance and instructions for use in the local language. In addition,
product samples need sometimes to be provided for local testing by
national reference laboratories.
In other EU countries, veterinary POCT products and their accessories
are divided into different legal categories based on their risk potential.
In Germany, substances for veterinary diagnostics may be subject to
German drug law and classified as fictitiousmedicinal products (26).
These IVD products for animals (e.g. reagents for enzyme assays,
electrolyte analysis or clinical haematology) are perceived as low risk
and can be marketed freely provided that they have been
manufactured under the Good Manufacturing Practice (GMP)
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standards. Those POCT products that are produced with the use of
epizootic pathogens or biochemical or biotechnological procedures are
regulated by the German Animal Health Act (27). In cases where
these tests are used to diagnose epizootic diseases, the Friedrich-
Loeffler-Institut (FLI) has jurisdiction over these products and issues
product licences that are required to market these tests in Germany.
All regulated POCT products are subject to post-market surveillance.
Few EU countries regulate both veterinary POCT kits and diagnostic
instruments. In Spain, POCT kits and instruments are treated
equally (28). In the Czech Republic, diagnostic instruments are
subject to notification while POCT kits require official approval (29).
Basic data about the applicant, product and manufacturing site must
always be provided. In the case of POCT kits, the adherence to GMP
principles is also reviewed. Products are then entered into a
corresponding national database and can be placed on the Czech
market. A similar approach is adopted in Slovakia (30) and partially
also in Croatia (31).
These examples illustrate the complexity of the regulatory
environment in the EU. Given that the national regulatory
requirements may be difficult to find, the European Medicines Agency
(EMA) recommends contacting the national competent authority
before marketing a product (32).
It is worth noting here that the EU has recently adopted new
legislation to regulate POCT products for human use (16). The
Regulation (EU) 2017/746 on IVD medical devices should guarantee
improved safety, quality and performance of these products by
increasing regulatory requirements (33). However, no efforts were
made to adopt even a basic level of regulation of veterinary POCT
products at the EU level (10).
United States of America
In the USA, veterinary and human medical devices are both defined
by the Federal Food, Drug, and Cosmetic Act (FD&C Act), paragraph
321h (34). Veterinary medical devices, including POCT products, fall
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under the jurisdiction of the United States Food and Drug
Administration (FDA), whose Center for Veterinary Medicine (CVM)
maintains regulatory oversight and can take an action if a product is
adulterated or misbranded. Although manufacturers and distributors
may request a review of their product labelling and promotional
literature, veterinary POCT products are not subject to any
compulsory pre-market clearance. All issues are addressed late in the
post-marketing phase, which is in direct contrast with the
comprehensive pre-market control of POCT products for human
use (35). While product manufacturers are exempt from compulsory
post-marketing reports, veterinarians and animal owners are
encouraged to report suspected adverse events and thus contribute to
safety monitoring. Adverse events associated with these veterinary
POCT products are processed by the CVM under the FD&C Act and
published on openFDA.gov (36).
Veterinary POCT kits for the detection of animal diseases or
immunological status are further regarded as veterinary biological
products. The authority for their regulation is provided by the Virus-
Serum-Toxin Act (VSTA) and detailed in Title 9, Code of Federal
Regulation (CFR), Parts 101–124 (37, 38). Jurisdiction over these
products is held by the Center for Veterinary Biologics (CVB) of the
United States Department of Agriculture (USDA) Animal and Plant
Health Inspection Service (APHIS).
The safety, purity, potency and efficacy of veterinary biological
products are ensured by a system of licences (38). Generally, only
licensed products may reach the USA market. The product licensing
has two levels depending on the intended use of the product (37). All
diagnostic kits are subject to primary evaluation of sensitivity,
specificity and reproducibility, which includes testing of proficiency
panels in multiple laboratories to demonstrate interlaboratory
equivalence. Additionally, POCT kits used during official control
and/or eradication programmes are further subject to a secondary
evaluation, which is more rigorous and involves extensive field tests
of characterised animal populations (e.g. infected herds or herds
imported from high-risk areas). Furthermore, the sale and distribution
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of these products may be controlled by CVB and limited to APHIS-
approved laboratories. In the post-marketing phase, the submission of
test results for each batch produced is required (36). Only batches with
satisfactory results are approved for marketing.
The CVB also issues establishment licences for USA based
manufacturers. The proposed manufacturing and testing facilities must
meet the requirements outlined in the VSTA (38). Licences are not
issued for foreign establishments. Foreign manufacturers have to
appoint a USA based representative that is required to obtain the
permit for distribution and sale and bears legal responsibility for
imported products. These products must meet the same licensing
requirements as those produced domestically.
Since 2018, licence and permit holders are also obliged to maintain a
registry of all adverse events, e.g. product failures that hinder the
discovery of the correct diagnosis, which are possibly related to their
veterinary biological products (37, 38). Adverse events need to be
reported to the CVB in an expedited manner or within 90 days
depending on their seriousness.
Japan
The basis of the regulation of human and veterinary medical devices
in Japan is specified by the Pharmaceutical and Medical Devices Act
(PMD Act) (39). The Ministry of Agriculture, Forestry and Fisheries
(MAFF) holds jurisdiction over affairs concerning veterinary medical
devices, including POCT, and releases legally binding Ministerial
Ordinances which further specify details of their regulation. The
regulation has a broad scope and includes all kinds of veterinary
POCT products regardless of their design and target analyte.
Analogically, the Ministry of Health, Labour and Welfare is in charge
of human POCT.
Three different steps are required to market POCT products (and
medical devices in general) in Japan (39). Each company has to
1) register its manufacturing plant by the local prefecture (Japanese
manufacturers) or by the corresponding ministry (foreign
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manufacturers), 2) appoint a marketing authorisation holder (MAH),
who obtains the manufacturing/marketing licence to demonstrate the
sufficiency of their quality systems, and 3) obtain a product approval
for each marketed device.
The procedures for the registration of manufacturing site and MAH
appointment are identical for both veterinary and human POCT
products. For product approval itself, separate systems apply. Human
POCT is divided into three classes based on the diagnosticrisk (40).
Generally, the devices belonging to the lowest risk class I can be
marketed based on self-certification, class II devices require
certification by one of the designated third parties and class III devices
need to obtain ministerial approval. During this most demanding form
of approval, the design, specification, active ingredients, assay
procedure, instructions for use, performance, method of
manufacturing, proposed storage, shelf life and other related
characteristics of the product are evaluated by the Pharmaceuticals
and Medical Devices Agency (PMDA). If all requirements are met,
the ministry grants product approval. The entire process may take up
to 12 months, excluding the time needed for correction of
documentation by the applicant.
Contrary to this, there is no third-party certification for veterinary
POCT and these products are therefore divided into two classes only.
Products that meet the calibration standards set by ministerial notice
no. 794 of 2017 can be marketed after notification of the competent
authority, which is the National Veterinary Assay Laboratory
(NVAL). The process is comparable to the self-certification of human
class I products. However, the list of calibration standards is still
rather limited and fewer than 50 products have been cleared via this
pathway so far. The majority of veterinary POCT products, including
all biological products (e.g. those used to diagnose infectious
diseases), therefore require ministerial approval. This procedure is
equivalent to the clearance process of human class III devices and
represents the most demanding form of product approval.
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In the post-marketing phase, on-site inspections to verify compliance
with GMP are scheduled every five years (41). The updating process
usually takes at least three months. The device approval itself does not
expire.
Discussion
Timely and accurate detection of animal diseases is crucial for animal
health management, sustainable food production and prevention of
zoonoses (4, 9, 42). The development of affordable and easy to use
POCT products is one of the important tasks of current veterinary
medicine. Their use in an uncontrolled environment by untrained
personnel places high demands on POCT characteristics, requiring
clear instructions, simple operation and maintenance, unambiguous
interpretation, robust performance, and wide transport and storage
conditions.
In the case of human POCT products, the above-mentioned
characteristics are tightly regulated by competent national authorities.
Indeed, approximately 30% of all countries worldwide have some
form of regulation concerning IVD medical devices for human
use (15). Among them, the EU, the USA and Japan represent locations
with high regulatory standards that try to harmonise their legal
requirements for healthcare products, including human medical
devices (19) and human and veterinary medicinal products (18, 43).
Nevertheless, their approaches to the regulation of veterinary POCT
products are strikingly different (Table I).
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Table I
Comparison of the regulatory system of veterinary point-of-care testing in the European Union, the United States of America and
Japan
Regulated products
Requirements
Manufacturing
approval
Competent
authority
Note
pre-market post-market
EU
EU level: POCT using electrical energy
(e.g. biochemistry analysers) CE mark
Decentralised
(local/national
authority)
Compliance with electromagnetic
compatibility and low voltage directives is
required
National level: from none to all POCT
(depends on the EU country) see Note see Note see Note National authority
If the EU country regulates veterinary
POCT, specific requirements are set at
national level
USA
All POCT CVM (FDA) CVM can take action if a product is
misbranded, adulterated or unsafe
Veterinary biological products
(e.g. diagnostic kits) Product licence
Reporting of adverse
events; reporting of test
results for each batch
Establishment
licence
CVB
(USDA-APHIS)
Products are classified based on their
intended use
Japan
Low-risk POCT (with established
calibration standards) Notification Good Vigilance Practice (all
products)
Good Post-marketing Study
Practice (selected products)
Manufacturing
plant registration
+ manufacturing
licence
NVAL (MAFF)
Requirements are similar to human POCT
from risk classes I and III, respectively
(e.g. compulsory adherence to GMP)
High-risk POCT (all other products) Ministry
approval
CE: European Conformity MAFF: Ministry of Agriculture, Forestry and Fisheries (Japan)
CVB: Center for Veterinary Biologics (USA) NVAL: National Veterinary Assay Laboratory (Japan)
CVM: Center for Veterinary Medicine (USA) POCT: Point-of-care testing
EU: European Union USDA-APHIS: United States Department of Agriculture Animal and Plant Health Inspection Service
FDA: Food and Drug Administration (USA) USA: United States of America
GMP: Good Manufacturing Practice
Rev. Sci. Tech. Off. Int. Epiz., 39 (3) 12
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The EU does not regulate veterinary POCT products at the union
level. The lack of harmonisation requires member states to rely fully
on their national legislation, which compromises the marketing of
existing veterinary products and hinders coordinated development of
new products at EU scale (42). The introduction of unified EU
regulation was discussed many years ago (32). However, the expected
level of such regulation remains unclear because the legal control of
the most closely related products (i.e. human IVD devices and
veterinary medicinal products) is in a transition phase. Whereas
human IVD devices are facing stricter regulations to improve their
general safety and performance (44), the administrative burden for
veterinary medicinal products has been reduced to strengthen
innovation and increase product availability (45).
In the USA, veterinary POCT products are divided into two legal
categories based on their target analyte. Those classified as veterinary
biologics are considered higher risk and require pre-market
approval (37). The remaining POCT products are regarded as
veterinary medical devices and are subject to post-marketing
surveillance only (34). In both cases, the requirements for placing the
product on the US market are clearly defined by law and may be
enforced by one of the competent authorities.
Finally, Japan is the only location that regulates human and veterinary
POCT products in a similar manner (39). Information about the
practical impact of such regulation on the quality and availability of
veterinary POCT products is anecdotal. Nevertheless, the abundantly
available data on the regulation of human medical devices show that
Japanese approval processes are among the most demanding
globally (46). This leads to many years of delay for the registration of
new products and consequently to limited access to cutting edge
technologies and to reduced product availability when compared with
the EU and the USA. Foreign manufacturers may even be forced to
maintain obsolete product lines to serve the Japanese market.
In contrast to human POCT products, veterinary POCT is divided into
only two risk classes in Japan. The vast majority of these products
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need to be cleared by ministerial approval, corresponding to the most
stringent approval procedure of class III human devices. This means
that numerous veterinary POCT products are subject to substantially
more rigorous regulation than their human analogues. This issue is
illustrated by the activities of the Japan Analytical Instruments
Manufacturers’ Association (JAIMA), which strives to achieve the
deregulation of veterinary IVD in order to establish a proper market
offer (47), and by official efforts to import veterinary IVD from the
EU to fill their shortage in Japan (48).
The right approach towards the regulation of veterinary POCT
products is difficult to determine. Although it seems attractive to
adopt the existing regulations for human POCT, it should be noted
that the global market for veterinary POCT products is considerably
smaller (US$1.4 billion versus 29.5 billion) and further fragmented by
animal species (49, 50). Therefore, all regulatory efforts should still
support the development of new products. A simple risk-based
approach to veterinary POCT products requiring pre-market approval
of higher-risk products and post-marketing surveillance only for
lower-risk products may be sufficient to regulate the safety and
effectivity of veterinary POCT products without compromising their
availability. Of the three locations studied, such regulation was found
only in the USA.
Conclusion
Veterinary POCT products play an increasingly vital role in everyday
veterinary practice. Although their quality is crucial for obtaining the
correct diagnosis, their legal status is rarely discussed. From the
regulatory perspective, veterinary POCT products are mostly regarded
as veterinary medical devices for IVD. Compared with human IVD
devices, their regulation is less consistent and lacks any form of
international harmonisation. The national approaches of the EU, the
USA and Japan differ in the scope of the regulated products as well as
in the degree of regulatory surveillance. The complexity of the
regulatory environment is especially apparent when comparing the
EU, which needs to be viewed as 27 individual states rather than a
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single market, and Japan, whose legal requirements on veterinary
POCT products equal or even exceed the requirements placed on
analogous human POCT products. On the other hand, the structured
risk-based approach of the USA could serve as an example for the
above-mentioned locations and also for other countries worldwide.
Acknowledgements
The authors would like to express their gratitude to Makoto Funabashi
(JAIMA, Tokyo, Japan) for providing initial insight into the Japanese
regulatory environment, Dr Zuzana Machovcova (University of
Veterinary and Pharmaceutical Sciences, Brno, Czech Republic) for
her critical review of the selected parts of the manuscript and finally
Dr Veronika Mancikova (Masaryk University, Brno, Czech Republic)
for her valuable comments during finalisation of the article.
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