Medical devices are tools used on humans to perform specific medical tasks, such as diagnosing a disease, treating a disability or studying a physiological state.
This is just a very brief overview of the detailed description that can be found in the new Medical Device Regulation. The rapid technological evolution of the Life Sciences sector has necessitated a revision of the directives that regulated these devices until the adoption of the MDR (Medical Device Regulation).
MDR – Medical Device Regulation
MDR is the acronym for European Regulation 2017/745, which definitively came into force on 26 May 2021.
The specific reasons for adopting the MDR are as follows:
- to offer greater safety guarantees over the entire life cycle of medical devices;
- to standardize regulation among EU member states;
- to respond quickly and promptly to market needs with the release of cutting-edge products.
The first point is an innovative development compared to the past. While previously the focus was on the requirements for marketing the device, the regulation now stipulates more specific criteria and measures in the preceding (clinical evaluation) and subsequent (monitoring and post-marketing) stages. The aim is to detect potential problems at an early stage and, at the same time, to offer increasingly advanced medical devices.
To achieve this, the standard outlines a number of measures, including:
- the introduction of significantly more detailed technical documentation;
- the registration of the device in the EUDAMED (European Databank on Medical Devices) database;
- specific procedures for reporting incidents and taking prompt action to resolve them.
Moreover, to ensure that devices effectively comply with the standard, on the one hand the MDR makes stakeholders such as manufacturers, importers and distributors of medical devices even more responsible and, on the other, it introduces a new role, that of the Compliance Officer.
The adoption of these measures through a Regulation (directly applicable in the individual States), rather than a Directive (which must only be compulsorily adopted in objectives), clearly demonstrates the strong desire to standardize the regulation of medical devices within the European Union.
One valuable and functional tool for this purpose is EUDAMED, a database that will make it possible to track the entire life cycle of the medical device. This ambitious project will come to fruition as soon as all six of its constituent modules are functional.
With the launch of the new mechanisms and the standardization of the system, it will become much easier to monitor the status of medical devices in Europe, improve their performance and respond more rapidly to new market demands.
Medical devices are subdivided into four classes (I, IIa, IIb and III) according to their intended use and resulting risk.
This subdivision is based on rules relating to the vulnerability of the human body which, as the MDR explicitly states, “should take into account the potential risks associated with the technical design and manufacture of devices”. To ensure that medical devices are safer, it was deemed necessary to review their classification on the basis of two criteria.
First, it was decided to expand the scope of application of the rules to many instruments that had not yet been classified. Consequently, today instruments that do not have a purely medical function, such as non-corrective contact lenses or equipment applied to cosmetics and instruments used for the prognosis and prediction of diseases or other health conditions, are also considered to be medical devices.
Secondly, it was considered essential to reclassify certain medical devices by downgrading them from the lowest to the highest risk class. To ensure greater safety, it was necessary to adopt stricter rules for assessing the risk associated with particular devices, such as implantable devices or software. According to the new regulation, these instruments now no longer fall under Class I, but under Class III, a change that entails more stringent requirements, more detailed documentation and the implementation of strict process control.
All this constitutes a major new development which, on the one hand, promotes the correct use of medical devices but, on the other, presents a challenge for the operators involved, who have to comply with numerous requirements and cope with all the associated bureaucracy.
Type of medical equipment for which translation is required
Translation is necessary for all medical equipment that is marketed in other EU countries.
Specifically, Article 10, Paragraph 11 of the MDR reads: “Manufacturers must ensure that the device is accompanied by the information referred to in Section 23 of Annex I in one of the official languages of the Union determined by the Member State in which the device is made available to the user or patient. The directions on the label must be indelible and written in a way that is easy to read and clearly understandable to the intended user or patient.”
Accordingly, in order to ensure the correct use of medical devices, the manufacturer must provide information that is comprehensible to the final recipient. It is therefore essential to translate material relating to the device into the language of the target country.
The translation must also meet certain quality standards, which is why it is controlled by the agent and may only be done by distributors and importers if they have a “quality management system including procedures to ensure that the translation of information is accurate and up to date” (Art. 16 p. 3).
Evidently, therefore, translation into other languages is crucial when placing medical devices on the market.
Requirements for documentation accompanying medical devices
Documentation required for medical devices in the MDR is much more detailed than in the past. This is evident simply from examining the list of information required under Annex II:
- descriptions and specifications of the device, including accessories and variants;
- information that must be provided by the manufacturer (e.g. labels, packaging, instructions for use);
- design and manufacturing information;
- general safety and performance requirements;
- risk-benefit analysis and risk management;
- product testing and validation (pre-clinical and clinical data and additional information needed for specific cases)
The spirit of the new regulation is to protect public health and safety, which is why it aims for more transparent information on each medical device.
It is therefore no surprise that, according to the regulation, the above-mentioned documentation must be presented in a “clear, organized, unambiguous manner and in a format that is easy to read”.
Translation for medical devices: professional requirements
The best way to ensure that documentation is properly translated is to entrust it to medical-scientific translation professionals.
To determine whether the identified provider is a professional, the following requirements must be met:
- deep knowledge of the source and target language for the document’s translation;
- specialization in the medical and technical/scientific field;
- ongoing professional development and knowledge of the current state of the sector;
- use of new language industry technologies.
These characteristics are essential to properly translate information accompanying such delicate instruments as medical devices.
Marketing for medical devices
Unlike the previous medical device directive, which did not include any advertising guidelines, the new regulation sets out rules for marketing related to these devices in Article 7.
Here, too, there are provisions consistent with the aim of maximizing transparency and protecting the ultimate recipients, namely European citizens.
When conducting marketing promotion, it is not permissible to mislead consumers, so the regulation prohibits:
- attributing functions and properties to the device that it lacks;
- creating erroneous impressions about treatment or diagnosis, functions, or properties that the device lacks;
- failing to inform users or patients about a potential risk associated with the use of the device as intended;
- proposing uses of the device other than those declared part of the intended use for which the compliance assessment was conducted.
These directions apply not only to written communication, but to any form of communication, including images, brands, etc.
Difference between medical devices and drugs
The MDR has also sparked an intense debate about the difference between medical devices and drugs.
First, let’s consider the definitions of both terms.
According to the MDR, a medical device is “any instrument, apparatus, appliance, software, implant, reagent, material or other item intended by the manufacturer for use on humans, alone or in combination, for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of diseases,
- diagnosis, monitoring, treatment, alleviation or compensation for an injury or disability,
- study, replacement or alteration of anatomy or a physiological or pathological process or state,
- providing information through in vitro examination of samples from the human body, including donated blood and tissue,
and which does not exert in or on the human body the principal action for which it is intended by pharmacological, immunological or metabolic means, but whose function may be aided by such means.”
The regulation also considers medical devices to be those for conception control or support and those specifically intended for cleaning, disinfection or sterilization of the above-mentioned devices.
The Italian Ministry of Health defines the term drug as follows:
- any substance or combination of substances presented as having curative or prophylactic properties in relation to human diseases;
- any substance or combination of substances that can be used on humans or administered to humans for the purpose of restoring, correcting, or altering physiological functions by exerting pharmacological, immunological, or metabolic action, or to establish a medical diagnosis.
While the former involves a physical action, the latter involves a pharmacological, metabolic, or immunological action.
However, this distinction has been challenged by the Meddev Guidance, aimed at implementing the standard, which argues that the definition of “pharmacological” should be revised, sparking a debate on the subject. According to Assosubamed, this revision would result in the risk of having devices that cannot be classified in either category, creating various problems for their management.
From the above, it is clear that medical devices constitute a rather complex field that is currently undergoing major changes. We will continue to explore this subject in future articles. In the meantime, feel free to contact us if you require a scientific/medical translation.