Recently, the European Parliament and the Council have produced one of the lengthiest and most thorough pieces of legislation in EU history, called the Medical Device Regulation (MDR).
It regulates every possible aspect of medical devices across the European Union, even linguistically. In fact, unlike its predecessors, the EU MDR language requirements are lengthy.
You may think that by being located outside of the EU, this regulation does not affect you, but you’d be wrong. The MDR affects all the medical devices that enter the EU markets, whether produced in the EU or beyond its borders.
If you do not take your time to learn about it and upgrade your operation to become MDR compliant, you could face some serious future issues. For example:
- You could risk dealing with major litigations.
- Your medical devices could be withheld from European markets.
- You could incur the financial costs of a product recall.
- You could lose market shares and long-term access to EU markets.
- You put your reputation at risk.
We will provide a detailed overview of the EU MDR language requirements and other related documentation requirements that the MDR imposes on your organization.
We will also walk you through some new compliance measures that make the MDR difficult to avoid. Finally, we will provide you with a timeline that you can use as a baseline to prepare your company and products.
The Medical Device Regulation is a new set of laws intended to create a European medical market with high standards. It has replaced, either partially or entirely, pre-existing directives that you are already familiar with:
- the Medical Device Directive (MDD), also known as the Council Directive 93/42/EEC;
- the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD).
This regulation’s stated goal is to “ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users” and to “set high standards of quality and safety for medical devices in order to meet common safety concerns.”
Among the key differences between the MDD/AIMDD and the MDR is that the sheer scope and breadth of the new regulation are astounding. Regulators have targeted a much wider net of products, and they have targeted them across the supply chain rather than simply as an end product.
There is some decent overlap with the definitions used in the older directives, but the MDR adds a few new important items to the definition. According to the MDR, a medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment, alleviation, or compensation of disease, injury, or disability.
- the investigation, replacement, or modification of the anatomy or state.
- providing information by means of in vitro examination of specimens derived from the human body, and which does not achieve its principal intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its function by such means.
A major change in the MDR is the inclusion of devices that up until now were not considered medical devices, such as the following:
- Contact lenses or other items intended to be introduced into or onto the eye.
- Products intended to be introduced into the human body through surgically invasive means intended to modify the anatomy or fixation of body parts (it does not include piercings or tattoos).
- Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous, or intradermal injection or other introduction, excluding those for tattooing.
- Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis, or lipoplasty.
- High-intensity electromagnetic radiation emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad-spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal, or other skin treatment.
- Equipment intended for brain stimulation that applies electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
There are two broad categories of documentation you will need to be MDR compliant:
- Documentation that will be reviewed mainly by compliance authorities. This type will not be limited to information about your devices but will include a lot of information about your manufacturing processes.
- Documentation that will be used by end-users (medical professionals and patients). Not only does it include technical information, but it also includes instructional information.
As a manufacturer, not only are you expected to design your products according to the MDR, but you also have to keep thorough documentation of the steps you take. These documents need to be updated regularly and can be required by European authorities at any given time. For instance:
- You need to establish a risk management system that needs to be maintained regularly.
- You should conduct clinical evaluations, including post-market clinical follow-up studies (PMCF).
- You need to keep updated technical records of custom-made and non-custom devices.
- You need to implement and regularly update a post-market surveillance system, including field safety notices (FSN).
- You need to keep an updated unique device identification (UDI) system.
- You need to have a quality management system (QMS) that is regularly updated. The more risk your product carries, the higher the standard for your QMS. It needs to address the at least the following:
- a strategy for regulatory compliance,
- identification of applicable general safety and performance requirements and exploration of options to address those requirements;
- responsibility of the management;
- resource management, including selection and control of suppliers and sub-contractors;
- product realization, including planning, design, development, production and service provision;
- handling communication with competent authorities, notified bodies, other economic operators, customers, and/or other stakeholders;
- processes for reporting serious incidents and field safety corrective actions in the context of vigilance;
- management of corrective and preventive actions and verification of their effectiveness;
- processes for monitoring and measurement of output, data analysis, and product improvement.
As you can see, the MDR has fairly strict documentation requirements. It doesn’t stop here either, you also need to make them available for a long duration. In fact, you need to keep all your technical documentation, the EU declaration of conformity, and a copy of any relevant certificates (including amendments and supplements) available for at least 10 years after the device has been placed on the market.
As we mentioned earlier, this documentation needs to be available across the supply chain. For instance, if you are located in China then you need to have an authorized representative in the European territories with the necessary documentation permanently available.
Aside from the process-related documentation, all your devices must come with the following technical documentation:
- Information to identify the manufacturer, and any safety and performance information relevant to the user. It can come in the device itself, the packaging, or in a booklet.
- You must also provide this information on your website and it needs to be updated regularly.
- You should include labels on the device and its packaging (single unit packaging, sales packaging, transport packaging in case of specific management).
- The labeling needs to be human-readable.
- Instructional information must be included with each device.
- Information about residual risks should be provided, including:
On top of the previous requirements, implantable devices need to come with some additional information:
- Identification information, including the device name, serial number, lot number, UDI, and the device model.
- any warnings, precautions, or measures to be taken by the patient or a healthcare professional about reciprocal interference with reasonably foreseeable external influences, medical examinations, or environmental conditions;
- any information about the expected lifetime of the device and any necessary follow-up;
- any other information to ensure safe use of the device by the patient, including overall qualitative and quantitative information on the materials and substances to which patients can be exposed;
Additionally, implantable devices must now come with implant cards (IC) that include some of this information. Of course, it has to come in an official EU language. Considering the space limitations you may deal with due to the size of the IC, you can use symbols in line with the ISO15223-2 standard.
*This is not an exhaustive list, and should only be viewed as a sample.
The MDR requires that you translate your documentation into the language of your target market. For instance, if you intend to sell your products in France, it must be in French.
If you intend to sell them in Germany, they must be in German. Depending on how many European countries you’d like to target, you may have to translate your documentation into more than 20 languages.
In fact, in some cases, it goes even further than that. For example, in Belgium, although they do show some flexibility for some of the process-oriented documentation, they are much less flexible when it comes to end-user documentation. In this specific case, you must provide them with documents in their three national languages: French, Dutch, and German.
As we mentioned before, these documents can be reviewed by European authorities at any given time in their chosen language. It includes technical documentation, audit, assessment and inspection reports, etc. On top of that, your authorized representative and the notified bodies should also have these documents.
The EU MDR language requirements continue beyond translation. You must adapt your documents to the end user’s experience, knowledge, education, or training. You must consider the format, the content, and the legibility while including any supplemental drawings and diagrams as needed.
For instance, if medical staff use your device exclusively, it should include the appropriate technical jargon in their native language. Depending on the device, the documentation may be as technical as needed. On the other hand, if the patients use the device (e.g., contact lenses), the language must be understandable for a lay person, and the tone should be more informal.
You absolutely have to provide all the aforementioned documentation in the required language of a Member State—especially end-user documentation. If you become aware that it is not fully translated, or is incomplete in any way, you are required to update it as quickly as possible or to withdraw your products from the market until you do.
If you do not, a Member State can restrict or outright prohibit your new devices from being made available on its market. As for devices already available on the market, Member states are fully authorized to withdraw them or even recall them until you provide updated, complete and correct information.
When simple mistakes lead to big problems.
A good example that can help you understand the risks associated with non-compliance with the EU MDR language requirements is a famous case of faulty knee replacement surgeries at the Saint Hedwig Hospital in Berlin, Germany.
Although the American manufacturer involved did include some instructional documentation in German, they did not translate the packaging of their devices. As a result, the staff of the hospital misconstrued the information on the packaging. They erroneously translated “non-modular cemented” to “non-cemented.” This exceedingly simple mistranslation had a pernicious effect. By the time the staff became aware of their mistake, 47 different patients had already been implanted with the wrong type of prosthetic.
Although this series of events cannot be fully pinned on the incomplete translation provided by the manufacturer, it is clear that it played a key role in the fiasco. As you can imagine, it led to a series of lawsuits and both the hospital and the manufacturer had to pay large compensation claims. Cases such as this one are undoubtedly the motivation behind the stringent language requirements of the MDR.
Considering the sheer depth of the requirements you may wonder if there aren’t any loopholes that you can take advantage of to reduce your documentation and translation burden. However, the MDR is fairly thorough and it has implemented some strict measures that improve its enforceability compared to the previous Directives. The key changes that make it difficult to circumvent are:
- If you are not located in the EU, you need to appoint an authorized representative located in the EU.
- Everyone involved in the supply chain can be liable.
- An updated European database on medical devices (EUDAMED).
Although litigation can scarcely cross international borders, your authorized representative can be held responsible for any issues with your device and its documentation. Furthermore, if there is an issue with a device, everyone in the supply chain can be deemed responsible, whether that’s the notified bodies, the distributors, or the manufacturer.
As for the EUDAMED, once you register a product on it, you have to continually update it over time. It is meant to contain all the information about your product and it will be available across all of the EU. It improves the effectiveness of customs control and their ability to detect problematic products sooner, while also facilitating any reviewing processes and audits.
First enacted on the 25th of May 2017, the Medical Device Regulation was meant to be implemented on the 26th of May 2020. However, due to COVID-19, regulators postponed its implementation until the 26th of May 2021. By the time of this reading, the MDR is the official regulation for medical devices across the EU.
That being said, it doesn’t mean that all medical devices need to be already compliant. In some limited cases, if you are willing to adopt parts of the MDR, then you can still keep your MDD-compliant products in the market for a few more years. In fact, you can still be issued with the older directives as of today and you’ll have until the 25th of May 2024 (or 2025 depending on your specific case) to become MDR compliant.
That being said, considering the depth and breadth of this regulation, it may be wise to leave your documentation to trained professionals with a medical background and expertise in this specific arena.