EU MDR language requirements — what manufacturers and distributors need to know
The introduction of the new Medical Device Regulation (MDR) aims to increase patient safety. An important component of this is the correct use of medical devices. To achieve this, professional users and also laypersons must be able to rely on comprehensible product information and instructions for use – a challenge with a regulation whose scope includes 24 official languages. In the following blog post, you will get practical answers on how the languages are regulated in the MDR.
- What are the language requirements of the MDR?
- What information is affected?
- How do the EU Member States implement these requirements?
- What does this mean for manufacturers?
- What responsibility must distributors assume?
- Further questions on language provisions and MDR
What are the language requirements of the MDR?
A glance at the MDR shows that Article 10 (11) very fundamentally requires manufacturers to include information in one or more official language(s) determined by the Member State in which the product is made available. In addition to labelling requirements, it also requires that this information be clearly understandable to the intended users or patients. The MDR becomes a bit more specific in Annex I, General Safety and Performance Requirements (GSPR), where Chapter 3 details the requirements for the information provided with the product. With regard to the linguistic regulations, Article 23.1 a) is of particular interest:
“The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.”
The MDR thus does not make a clear distinction between professional users and laypersons, but refers to relative values that must be observed in the preparation of instructions for use and information, without specifying these more precisely. Even with the passage that the information “is understood without difficulty”, the MDR does not set any concrete linguistic requirements. However, a clear instruction follows in section c), which requires that the labels must be presented in a way that is legible for humans. For further information on the language provision, Annex II of the MDR must also be consulted. In the comments on the technical documentation, Article 2 once again states that the labelling as well as the instructions for use must be available “in the languages accepted in the Member States in which the product is to be sold”.
This requirement can be partially circumvented by referring to internationally recognized symbols and identification colours. “Where appropriate,” the MDR in Annex I specifies that the information provided must be in this form, conforming to harmonized standards or specifications. The revision of ISO 15223-1:2016 Medical Devices: Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements is available as a draft (ISO/FDIS 15223-1 (Ed 4)). In addition, the new standard ISO 20417:2021 Medical devices – Information to be supplied by the manufacturer – has been published and, like ISO 15223-1:2016, is included in the European Commission’s draft standardization request. However, if none exist for the area to be covered, the symbols or identification colours must be explained in the product documentation, which means that they are again subject to the language requirements.
What information is affected?
The MDR becomes only slightly more concrete when it comes to identifying the information affected by the language provisions. The relevant Chapter III in Annex I requires:
“Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate.”
This information may be placed on the product, on the packaging or in the instructions for use. In addition, the MDR states that this information must also be available and updated on the manufacturer’s website, if the manufacturer maintains one. Regarding eIFU,Commission Regulation (EU) No. 207/2012 on electronic instructions for use of medical devices still applies until it is superseded by an implementing act under the MDR. In the explanations on technical documentation in Annex II, there is also a list of the information that the manufacturer must include in the respective official languages, namely the label(s) on the product and its packaging (single unit packaging, sales packaging, transport packaging) as well as the instructions for use.
At this point, it should be noted that in the case of stand-alone software and apps, the user interface (GUI) is considered to be the instructions for use if no such instructions are otherwise provided. This means that it falls within the scope of MDR Article 10 (11) and must be available in the specified official languages.
On the other hand, marketing materials are not explicitly mentioned in the MDR. In MDR Article 2 (13, 14), instructions for use are defined as “information provided by the manufacturer to inform the user of a device’s intended purpose and proper use and of any precautions to be taken”, and labelling as “written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices”. The MDR thus provides very broad definitions, which in turn leave the implementation for the specific language provisions to the individual Member States. Looking at other regulations, however, it can be stated that marketing information is generally considered to be part of the labelling and should therefore be translated depending on the requirements of the individual countries, specifically if the information relates to safety and performance or the benefit-risk ratio.
The same applies to the summary of safety and clinical performance, as required by MDR Article 32: It, too, must be written in a way that is understandable to the intended user and, if relevant, to the patient, and is thus subject to the language provisions of the individual Member States, which may require translation into official languages.
How do the EU Member States implement these requirements?
In view of the above, it is not surprising that the open definitions and linguistic provisions with little specific wording lead to very different national implementations. Because the introduction of the MDR also transfers a great deal of responsibility to the Member States, not all countries have yet published the corresponding legal texts. However, the implementations already available show that the language requirements tend to remain the same, but are in part more detailed. In view of the previous regulations under the MDD as well as already published new requirements with regard to the instructions for use (which are usually subject to the strictest requirements), the implementations can be categorized into three possible groups:
– By law, there must be a translation without exception.
– By law, English can be used without conditions.
– By law, English can be used for professional users under certain conditions.
Only recently, for example, was the language regulation confirmed in Norway, where the current regulation will remain in place. Norway generally requires that the information provided by the manufacturer be in Norwegian. In the case of medical devices for clinical investigations, another language may also be used. As soon as a medical device is used directly by patients, Norwegian information is mandatory. Exceptions are possible, but must be requested in writing. The regulation explicitly states that the requirements are interpreted very strictly and the request must be well justified. Belgium has also presented a strict interpretation of the language regulation in a draft, in which all information for lay users must be provided in all national languages (French, Dutch and German). For products used exclusively by healthcare professionals, the information may exceptionally be provided in English, but the user has the right to request the information from the manufacturer in the national language of his or her choice.
These two countries thus distinguish in their interpretations between professional users and lay users – a distinction which the MDR does not make and which shows how complex the situation is for manufacturers in the European single market.
What does this mean for manufacturers?
As the examples outlined show, manufacturers of medical devices cannot avoid dealing with the language requirements of each individual country in which they wish to market their products. This also means that the internal processes for the respective countries are to be adapted accordingly so that the products are delivered to the respective countries with correct information or that users receive instructions for use in the local language upon request.
What responsibility must distributors assume?
The MDR also makes distributors and importers responsible for compliance with the language requirements: According to MDR Article 14 (2b), they must check that the information required under Article 10 (11) is available and translated accordingly. Documented processes are fundamental when it comes to accounting for compliance with these requirements. Article 14 of the MDR does not provide a legal requirement that a distributor must implement a QMS. However, this changes if country-specific adaptations to a medical device are made, such as translating the instructions for use and other documentation. In this case, the distributor assumes responsibility for these and requires a QMS that must be certified by a notified body (MDR Article 16).
This means that all distributors must neatly document compliance with their obligations through processes. This is also the reason for the general recommendation to all distributors to implement a QMS. A QMS provides assurance that only legally compliant medical devices are distributed, that non-compliant, defective or unsuitable products are identified, and that traceability is ensured. For more information on how medical device distributors meet the requirements of the MDR, click here.
Further questions on language provisions and MDR
Our team would be happy to assist you with regulatory compliance and specific questions regarding the MDR or the language provisions. Although the MDR has been applied in all EU Member States since May 26, 2021, there are still some missing national implementations that define country-specific elements, including the language requirements. We are monitoring the developments in all Member States and our team of experts is always available to assist you. Do not hesitate to contact us.