Medical devices intended solely for use in animals are still not subject to a specific and harmonized regulatory framework at European level. The requirements of Regulation (EU) 2017/745 (MDR) therefore do not apply to these products.
Can a manufacturer market its veterinary device without further regulatory requirements?
The manufacturer must verify the existence of applicable requirements at Community and national level.
At Community level, some regulatory requirements will apply with regard to the general principles of consumer protection, information and depending on the composition of the veterinary device (for example requirements relating to ionizing radiation, animal by-products, future provisions relating to legislation on artificial intelligence).
It is important to note that there are very few, if any, specific requirements on the safety and performance of these products for the animal and their users.
If these Community provisions are included in the legislation of the Member States, the absence of a harmonized framework creates different approaches at national level. The following situations will be observed for medical devices for veterinary use:
- No specific provisions: the general provisions will only be applicable.
- The qualification of some devices as veterinary medicinal products or biocidal products: the competent authorities of the Member States adopt a risk-based approach on a case-by-case basis with regard to the existing regulations for veterinary products. The existing provisions relating to obtaining authorisations prior to placing on the market and manufacture, maintaining authorisations, requirements relating to surveillance and vigilance will therefore apply.
- Qualification as fictitious veterinary medicinal products: this case will concern certain devices. However, the requirements for marketing and manufacturing authorisations will not apply, as these products are considered to be low risk.
- Qualification as veterinary health products: depending on the countries concerned, pre-marketing requirements (prior registrations, notifications, or authorizations) and post-marketing requirements (renewal of authorisations, notification of changes, vigilance, archiving) will apply.
- Some national legislations also clarify the situations for which CE marked medical devices can be used for veterinary purposes.
Is this regulatory context an opportunity for manufacturers of medical devices?
A regulatory framework for veterinary devices strictly identical to the existing one for human health would not be relevant, in particular to promote innovation and the supply of clinical solutions by this industry for a large number of different animal species, with regard to the size of the sector and the pricing mechanism compared to the medical device industry.
Currently, the 3 categories of costs associated with the assessment of the weight of regulatory compliance are generally in favour of the current regulatory situation for veterinary devices:
- Information costs are the costs associated with seeking and obtaining information about regulatory processes and processing the information obtained. Given the complexity of identifying the applicable requirements and their completeness, the manufacturer can expect high costs relating to this expenditure item (research and analysis time, advice). However, these costs will not be drastically higher than for medical devices. Even if the harmonized framework provided by the MDR facilitates the identification of the applicable requirements, their translation as well as the definition of the compliance method also require investments.
- Specification costs are the costs of adapting products and services to different requirements. The existing requirements for veterinary devices do not repeat the same requirements as those applicable to medical devices. For medical devices qualified as veterinary medicinal products when intended for animals, some of the data and practices developed and obtained for the human intended use may be used to adapt the product and the organization to the applicable veterinary requirements. They are therefore weaker.
- Conformity assessment costs are the costs of demonstrating compliance with requirements such as additional laboratory tests, certificates, inspections and audits. Overall, these costs will not be higher than those applicable for medical devices.
Thus, with regard to the regulatory compliance effort in relation to existing requirements as well as the associated time to market, the current regulatory situation for veterinary devices is an advantage compared to that of medical devices.
It should however be noted that the safety and performance requirements listed in the MDR also contribute to the adoptability of the product by users and prescribers with, for example:
- The requirements relating to the design process which push to identify and meet the real needs of patients and users in the development of the technical solution.
- Analysis of the state of the art to develop a device providing clinical benefit compared to current solutions.
- The information provided by the manufacturer which must be adapted to the users, and which must inform about the residual risks.
The methodological approach that I recommend for a manufacturer who already has a medical device that he wishes to position in animal health and promote its adoption by users and prescribers is as follows:
- Determine the clinical needs to be satisfied according to the target animal species with regard to the state of the veterinary clinical art.
- Identify the applicable regulatory requirements according to the targeted marketing countries as well as the relevant regulatory requirements to follow.
- Define the marketing feasibility with regard to the specificities of the animal health sector.
- Perform an impact analysis on design and development data:
- Analyse the impact of the animal intended use for the target species and the associated users on the initial design input data as well as the verification and validation data available.
- Carry out the relevant bridging studies to verify and demonstrate the safety and performance for the animal, the usability and the confirmation of the clinical benefit for the animal.
- Use an approach based on risk management throughout the process.
- Ensure the definition of the information to be provided to the user.
- In the post-marketing period:
- Ensure compliance with applicable regulatory requirements (eg renewal of authorisations, vigilance).
- Ensure obtaining user feedback and analysis to verify the maintenance of the security and performance claimed. Whether or not there are specific vigilance requirements in relation to a competent authority surveillance, this analysis should lead when applicable to the implementation of corrective measures aimed at eliminating the cause of a case of potential or actual non-compliance or of another undesirable situation. Related communication to users should be put in place when relevant.
- Carry out relevant clinical monitoring to confirm that the positive benefit/risk ratio for animal health is maintained.
OHC and its partners specialized in animal health support you in analysing the feasibility of positioning your medical devices in animal health and in the marketing process. Address your needs:
- Via the contact form on www.onehealthcompliance, or
- By email: email@example.com.
July 1, 2022