Impact of the EU language regulation on Medical Devices on manufacturers and distributors

Impact of the EU language regulation on Medical Devices on manufacturers and distributors

Qui định của EU về ngôn ngữ trên các Thiết bị Y tế tác động thế nào đối với nhà sản xuất và nhà phân phối?
Qui định của EU về ngôn ngữ trên các Thiết bị Y tế tác động thế nào đối với nhà sản xuất và nhà phân phối?

The medical industry in general and medical equipment in particular have quite strict requirements for translation. This comes from a good reason: Incorrect medical device translations can seriously affect operation and put the patient in danger.

The introduction of the Medical Device Regulation (MDR) 2020 aims at increasing patient safety. An important part of this is the correct use of medical devices. To this end, professional users as well as those with no or limited expertise have the ability to rely on product information for proper use. One challenge is that the new regulation covers 24 official languages.

MDR nhằm mục đích tăng cường sự an toàn cho bệnh nhân
MDR aims tat improving patient safety

What language requirements do MDRs have on medical devices?

First of all, in Article 23.1a), the regulation clearly states:

 “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.”

Therefore, the MDR does not make a clear distinction between professional and unprofessional users, but refers to relative values that must be observed in the preparation of instructions for use and product information, and not have more precise definition for these values. Even with the information “readily understood by the intended user” (which means “understood without any difficulty”), the MDR does not impose any specific language requirements. However, the following clear instructions in c), requiring that the labels be presented in a human-readable format.

Annex II of the MDR also provides more information on language provision. In the comment on the technical documentation, Article 2 again states that the labels and instructions for use must be available “in the languages accepted in the Member States where the product is to be sold”.

The language requirement in the MDR may be replaced by internationally recognized symbols and colors. “Where appropriate,” the MDR in Annex I specifies that the information supplied should be in this form, conforming to the harmonised standards or CS. Reference should be made to the information on the relevant symbols used in the standards:

  • The corrected version of ISO 15223-1 in March 2017: 2016 – Medical devices: Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: The general requirement is available as a draft (ISO / FDIS 15223-1 (Ed 4)).
  • The new standard of ISO 20417: 2021 Medical devices – Information to be supplied by the manufacturer – has been published and, as ISO 15223-1: 2016, was included in the European Commission’s draft standardization request.

However, in the case of areas where the device is used where uniform standards for symbols or colors have not been adopted, they must still be explained in the product documentation, which means that they must comply with the language requirements.

What information is affected by the MDR language requirements?

Labeling, packaging and instructions for use

The MDR does not concretize the information affected by the language requirements. In the chapter of in Annex I, it is stated:

“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.”

Information may be 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 kept up to date on the manufacturer’s website, if the manufacturer has one. Regarding the eIFU, Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices shall apply until it is replaced by a regulation or equivalent document applying the MDR.

In Annex II of the MDR, there is also a list of information to be supplied by the manufacturer in the respective official languages, namely the product label and its packaging (single packaging, sales packaging, transport packaging) as well as instructions for use.

Language on Medical Software User Interface (GUI)

Medical software is also considered to be the manual or to manage information about the operation of the device so it also needs to be covered by Article 10 (11) of the MDR and must be available in the specified official languages.

Stand-alone mobile apps and software, the user interface (GUI), or software displayed on the device are under by the MDR language requirements.

Sales and Marketing Materials

Marketing information is often considered part of labeling and therefore needs to be translated depending on country-specific requirements, specifically if the information is related to safety and performance or risk–benefit ratio when using medical devices.

MDR is not clearly mentioned in terms of language in medical device marketing materials. In Articles 2 (13, 14) of the MDR, instructions for use are defined as “the 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 the labeling as “the 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 provides very broad definitions, so the implementation of specific language provisions will be determined by individual Member States.

The same applies to summary of safety and clinical performance. Article 32 requires that content related to medical devices be written in a way that is clear to the intended user and, if relevant, to the patient and therefore subject to the language provisions of each Member State, translation into official languages should be available upon request.

How do EU members apply the requirements of the MDR?

With the aforementioned viewpoint, it is not surprising that open definitions and language provisions with a few specific words lead to very different implementation among the countries. Since the introduction of the MDR also transferred a great deal of responsibility to Member States, not all countries have published corresponding legal documents. However, the current implementations show that the language requirements tend to be maintained, but are somewhat more detailed. Implementations can be classified into three possible groups:

  • According to the regulation, a translation is required.
  • According to the regulation, English can be used unconditionally.
  • According to the regulation, English can be used for professional users under certain conditions.
Các thành viên EU thực hiện các yêu cầu của MDR như thế nào?
How do EU members apply the requirements of the MDR?

What impact does MDR have on medical device manufacturers?

First of all, medical device manufacturers will inevitably find ways to respond to and conform to the MDR requirements for the language displayed on their products. However, language restrictions are limited to the countries in which they want to market and sell their products. This also means that the internal processes of the respective countries must be adjusted accordingly so that the products are shipped to the respective countries with correct information or the user receives instructions for user in local language upon request.

In general, MDR will put more pressure on manufacturers because language conditions can hinder the speed of market development as well as easily violate other national regulations in the event of incorrect translation.

Are medical device distributors required to comply with the language requirement in the MRD?

The MDR also holds distributors and importers responsible for complying with language requirements: According to Article 14 (2b) of the MDR, they must check that the information is available upon request under Article 10 (11) and that it is properly translated. Documented procedures are mandatory when considering compliance with these requirements.

Article 14 of the MDR does not provide a legal requirement that a distributor implement a QMS. However, this will change if country-specific adjustments are made to the medical device, such as translation of instructions for use and other documents. In this case, the distributor is responsible for these and requires the QMS to be certified by a competent authority (Article 16 of the MDR).

Distributors must clearly document compliance with their obligations through processes. This is also the reason it is recommended for all distributors to implement a QMS. The quality management system guaranteed that only legally compliant medical devices are distributed, non-compliant, defective or nonconforming products are identified and traceability is ensured.

Impact of the EU language regulation on Medical Devices on manufacturers and distributors

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