By Sandra Dejean, PharmD, founder of One Health Compliance
Originally published on LinkedIn (September 2017)

Introduction

This article is the first in a series dedicated to the regulatory situation of veterinary medical devices in the European Union. It is drawn from my doctoral thesis in pharmacy, awarded the Académie Nationale de Pharmacie Prize in 2016 and published for the first time in 2017.

At the time, the question of the regulatory framework applicable to veterinary medical devices was almost entirely overlooked: few publications, little public debate, and a European Commission that had not yet placed the subject on its agenda. Nearly ten years later, has the situation evolved? I will return to this assessment in an upcoming article.

In the meantime, here is the analysis as I published it in 2017, for the record and to provide some context.

Medical devices have a role to play in diagnosis, prevention, monitoring, prediction, prognosis, treatment of veterinary diseases.

For example, some implantable products (hip prosthesis, pacemakers, filling biomaterials) can improve a pathological state, biomechanical conditions, life expectancy of animals. Some orthosis help animals to recover similar pre-traumatic mobility and autonomy with improvement of quality of life observed by pet owners. A device has been developed to help assessing pain in cats, dogs and horse based on the ECG signal to adapt analgesic treatment.

Medical devices can also give alternative solutions by answering to economic constraints of the livestock sector while maintaining animal health and welfare. A low-cost bovine intra-uterine device has for example been developed and provides alternative to physic and chemical castration. Devices derived from digital technology will be able to bring solutions for early diagnostic of diseases and for targeted treatment among a large group of animals.

Need for clarification in regulatory framework for medical devices used in the veterinary field has been identified

Medical devices used in veterinary field are not included in the scope of regulation concerning medical devices. Indeed, they are not specifically intended to be used for human beings for medical purpose. The status of “veterinary medical device” has thus no regulatory meaning and there is no specific European legislation for these products to date.

This situation in EU has been highlighted during the revision of the regulatory framework for veterinary medicinal products and the recast of medical devices directives. In response to the public consultation in the framework of the recast, Belgium has for example identified that veterinary medical devices should be regulated at a European level. Finnish competent authority answered that directive 93/42/EEC concerning medical devices should be amended to cover these products when intended for veterinary use. During the process for revision of the regulatory framework of veterinary medicinal products, the Committee for Medicinal Products for Veterinary Use (CMPV) has provided that for medical devices used in veterinary sector:

• Clarification of classification of these products should be performed since some of them are treated as (fictitious) medicinal products. Indeed, some EU member countries national laws include some veterinary medical devices in the definition of veterinary medicinal products although classified as medical devices when used for human beings. In addition, Competent Authorities can perform a product by product classification to assess if a veterinary medical device fulfills the definition of a medicinal product by presentation.
• Have a harmonised and simple approach for their placing on the market.
• Introduce simplified legislative controls to verify the safety of such products.

To date, the revision of the regulatory framework for veterinary medical devices is not planned by the Commission.

Considerations regarding a future decision-making process for veterinary medical devices regulatory framework

The role of medical devices in the veterinary sector is anticipated to increase in EU because of:

• Growing number of companion animal population and their social and economic impact,
• The place of livestock farming as agriculture remains a major activity in EU,
• Public opinion and European policy for animal welfare.

To confirm the need for action at EU level and the best option to introduce, European Commission uses regulatory impact assessment (IA) tool issued from its “better regulation” objectives. Impact assessment is a process that prepares evidence to help political decision-makers on the advantages and disadvantages of possible policy options by assessing their potential impacts.

First step of this process consists in the verification of the existence of a problem (or need). Especially, the process aims to (i) identify who is affected; (ii) estimate the scale of the problem; (iii) analyse its causes; and (iv) assess the likelihood that the problem will persist in the absence of EU policy intervention. For veterinary medical devices matter, the problem identification step should assess whether:

• The current situation enables to identify essential requirements to provide and ensure a high level of protection of health and safety for animals for whom these devices are intended;
• The current situation delivers a harmonised framework throughout EU according to the status given to the veterinary medical device and the subsequent requirements that the manufacturer should comply with.

Another step of IA consists in identifying options (regulatory/non-regulatory approaches) that could be relevant to solve the problem previously identified. Based on the “veterinary medical device” concept, it seems relevant to assess options that would provide essential requirements and approach for placing in the market (CE marking) aligned on those for medical devices. Options providing that only products classified as high-risk veterinary medical devices would be concerned by reinforced requirements should also be considered.

Impact analysis process provides that selected options are assessed for relevant economic, social and environmental impacts. For this specific matter, economic impact should be reviewed in terms of (i) compliance and administrative costs to conform with requirements of the proposed options and (ii) support for innovation (do the proposed options facilitate the introduction and dissemination of new technologies and products?). Indeed, the “veterinary medical devices” sector gathers characteristics from both medical devices and veterinary health sectors. Medical devices sector is especially made from small and medium enterprises with high innovation capacity. Veterinary health sector is particularly sensitive to financial constraints notably because subjected to the will to pay of owners and regulatory administrative costs augmented to species numbers. Decision-process regarding the regulatory framework for veterinary medical devices should thus not introduce economic concerns that could be a burden to development and use of innovative solutions for animal health.

Conclusion

As noted in the introduction, this article was written and published in 2017. Nearly ten years have passed since those initial analyses, and the regulatory framework for veterinary medical devices in the European Union remains a topic of interest. What has changed? What opportunities and risks does this create for companies developing these products today?

I will soon be dedicating a series of articles to this review. Stay tuned.

→ Are you working on a project involving veterinary medical devices or diagnostics, and you have questions about the applicable regulatory framework or the strategy to adopt in this context which can still be difficult to navigate? Let’s talk for 15 minutes.

References

[1] Dejean S. Veterinary medical devices: what is the situation of the revision of the regulatory framework in Europe? LinkedIn, September 2017. [Online]. Available at: https://www.linkedin.com/pulse/veterinary-medical-devices-what-situation-revision-framework-dejean/

[2] Dejean-T. S, Implementation of a Regulatory Framework for Veterinary Medical Devices: Impact Analysis [Thesis]. Lyon, France: Université Claude Bernard; 2016.

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