Analysis of MDR 2017/745 from a translation perspective
The entry into force of the new EU Regulation on medical devices 2017/745 (MDR 2017/745) has generated, as it could not be otherwise, a great movement at all levels in an industry that accounts for hundreds of billions of Euros worldwide, and whose good health keeps it as one of the leading industries in several of the developed countries.
It is therefore not surprising that, around this regulation, whose guidelines are going to govern this very important industry, a multitude of synergies have been created to explain, detail, compare and debate it. These synergies are moving in different directions around the MDR, its differences from the previous Regulation, its practical application for the classification of “frontier” medical devices, its positive aspects, the new administrative burden for companies in the sector, etc.
I myself, as director of Mediwords and specialist translator, have attended several webinars and meetings concerning MDR 2017/745, its practical applications and its management, administrative, marketing and licensing implications. However, we have not yet seen an analysis from the point of view of languages and translation, a part of which, although it is present and included in the new MDR (as it was in the previous one) and influences the workflow of the companies that manufacture, market and distribute these medical devices, is not usually taken into account in the initial stages of working on new products. It is often later, when it is more expensive, technically and commercially speaking, when it is noticed that this abandonment of translation work can influence commercial performance. In extreme cases, this can lead to business losses, fines, bad reputation and delays in the marketing of products.
Mediwords, a specialist in medical translation and for the medical devices sector, has analysed the MDR 2017/745 and shares with everyone what it has learned from the document, applicable to companies in the sector.
We are not going to discuss issues such as the classification changes that are going to affect various medical devices, or the definition of the term medical device’ itself, or the legal requirements for manufacturers not established in the European Union to have an authorised representative on it; all these points are duly dealt with and covered in excellent articles from other colleagues and specialised companies in the sector that I recommend reading.
As we have indicated, we will look exclusively at the role of translation and languages in the implementation of the new regulation and how it may affect manufacturers, producers, marketers and distributors of medical devices.
In general, unless otherwise stated, the MDR requires that written communication and documentation between the different participants in the various stages of the manufacture, analysis, management, authorisation, marketing and distribution of medical devices be made in the language designated by the Member State, usually the official language of that State. Except in specific cases, we understand that all States will require compliance with this requirement.
This documentation generated does not only refer to product labelling, but also includes the clinical trials and tests carried out, the documentation accompanying the product (operating manuals, interfaces of software products, leaflets, instructions for use, etc.), as well as information for patients and healthcare professionals.
Already, in Chapter MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT; Article 10′ General obligations of manufacturers’, point 11 is stated:
11.Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.
And in point 14 of the same article:
14.Manufacturers shall, upon request by a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language determined by the Member State concerned.
On the other hand, Article 11′ Authorised representative’, point 1 (d) mentions the capacity and obligation of the latter to respond in the language established by the Member State to the various requests which may be made available by the various State agencies. Here, it is the authorised representative who can “inherit”, depending on the agreements with the manufacturer, the obligation to provide the translated documentation.
1.Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.
The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:
(d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;
Also in Article 16 “Cases in which obligations of manufacturers apply to importers, distributors or other persons”, points 3b and 4 include how distributors and importers may also have documentary and management obligations in which the information must be translated into the language of choice of the Member State in which the product is marketed.
- b) Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy.
4.At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use.
When the Regulation mentions in its Article 19 EU Declaration of Conformity, it requires from point 1 that, with minimum criteria, certain information be translated into the official languages of the Member States.
1.The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.
Chapter IV Notified Bodies, Article 41 Language requirements, states that a specific set of documentation referred to in Articles 38′ Application by conformity assessment bodies for designation ‘ and Article 39′ Assessment of the application’ shall be drawn up and translated into the languages marked by the Member State, which may be an agreed common language, or the official language of the Member State.
- All documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languages which shall be determined by the Member State concerned. Member States, in applying the first paragraph, shall consider accepting and using a commonly understood language in the medical field, for all or part of the documentation concerned. The Commission shall provide translations of the documentation pursuant to Articles 38 and 39, or parts thereof into an official Union language, such as is necessary for that documentation to be readily understood by the joint assessment team appointed in accordance with Article 39(3).
Chapter V’ Classification and conformity assessment’, Section 2 Conformity assessment Article 52 Conformity assessment procedures, refers in point 12 to the possibility that, at the request of the Member State, a series of technical documents may have to be translated into the official language of the Member State.
12.The Member State in which the notified body is established may require that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 7 and 9 to 11 be made available in an official Union language(s) determined by that Member State. In the absence of such requirement, those documents shall be available in any official Union language acceptable to the notified body.
Chapter VII POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE, Section 2 Vigilance, Article 89 Analysis of serious incidents and field safety corrective actions, paragraph 8 establishes the requirement for the drafting and/or translation of security information.
8.The manufacturer shall ensure that information about the field safety corrective action taken is brought without delay to the attention of users of the device in question by means of a field safety notice. The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken.
In ANNEX II TECHNICAL DOCUMENTATION, point 2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER, it is established which documentation must be submitted for a medical device and what is the translation requirement for it:
A complete set of:
— the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold; and
— the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold.
In Annex XV Clinical Investigations, CHAPTER II DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION, point 3. Clinical investigation plan, paragraph 3.1.5 states that the overall summary of clinical investigation concerning medical devices should be in the official language determined by the Member State.
3.1.5. Overall synopsis of the clinical investigation, in an official Union language determined by the Member State concerned.
In conclusion, it should be pointed out that this new Regulation essentially leaves it to the discretion of the Member States to request or require that certain types of documentation be translated into one or more official languages of that State.
This is likely to result in a disparity of views from one State to another. Possibly, in countries where there is a tradition of accepting documentation in English, for example, this will not change, however, in countries such as Spain, the provision of documentation in Spanish will remain a priority, regardless of whether it is generated in German, French or mainly in English.
Another important point to highlight from the reading of this regulation is that the responsibility for providing the required documentation in the appropriate languages lies with the manufacturer, or alternatively with the authorised representative in the EU.
Finally, this being a very personal opinion, I understand that this regulation reinforces the need to integrate translation and localisation (of software) into the processes of research, authorisation and marketing of medical devices, at least in countries such as Spain. This integration must be done from the initial levels, since late incorporation is a missed opportunity, and in many cases a delay and economic losses, easily avoidable.
- On 09/03/2018