Michael Kemmann is Managing Director of ADAPT Localization Services, a language service provider specializing in translation services for life sciences and technology companies headquartered in Bonn, Germany. He holds an M.A. degree in German and English language and literature from Bonn University and a certificate in Regulatory Affairs for Medical Devices from the University of Augsburg.
Incidents like the current Covid-19 pandemic, which are considered once-in-a-lifetime events — at least at the time they are happening — are bound to raise debates about what impact they will still have on business, and life in general, once they lie behind us. While there is, as always, lots of speculation, wishful thinking, and the occasional pseudo-prophetic attitude, along with a somewhat excessive use of terms like “disruption” or “reshaping,” there can be little doubt that several of the changes forced upon us by the crisis will have a lasting effect beyond its duration.
This is also true of the language industry. Working remotely and its implications — so omnipresent in many media these days — hasn’t really been much of a novelty for many LSPs, which have been digitally connecting internal and external project teams from different parts of the world for years already. Some industry sectors, however, had to adapt to changes in their usual environment which are, at least in part, likely to last.
One of these sectors is translation for certain medical products. It would be unfair to describe this as entirely static before the outbreak of the pandemic. However, its stakeholders now certainly have to deal with a few challenges less known to them before, specifically in connection with the atypical speed at which tests, vaccines, and medicines are developed and eventually marketed. With a specialist term like “rolling review” — a process under which public health authorities like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) start evaluation of preliminary laboratory and clinical data for a medical product as it becomes available from studies that are still ongoing, instead of requiring it to be complete at the start of the review process — becoming almost commonplace, a kind of “agile” approach has taken hold in a field where it was formerly viewed with mistrust.
The urgency and hurry under which COVID-19 tests and vaccines were developed, and the speed with which they were reviewed and approved by the health authorities, was rather unprecedented, and so was the translation process connected to them. In a traditional medical translation scenario, work on the language versions of the Instructions for Use (IFUs) would have started once the product was more or less finalized, with any feedback from the responsible health agencies like the FDA or the EMA — or a notified body in the case of medical devices intended for the European market — already implemented and marketing authorization underway. In the frenzy of the pandemic, the translation process frequently started on mere drafts which had already received their second or third major update before the first round of translations was even finished.
It is maybe unlikely that this will become a blueprint for the majority of future translation projects in the medical field. Still, a discussion has started among industry, regulators, and other government bodies trying to determine if there aren’t lessons to be learned from the exceptional situation of the pandemic, lessons which could help speed up the often lengthy and tedious review and marketing authorization processes for novel drugs and other medical products. This could foster medical innovation and allow the industry to provide better healthcare to patients sooner, even without a public health emergency, without compromising the safety and effectiveness of the products. If this discussion leads to results, it might permanently add a touch of agility to the translation processes employed by the medical industry, as well.
And yet, in the end it may not even be COVID-19, but rather the recent advent of the European Union Medical Device Regulation (MDR) in May this year and its sibling, the in-vitro diagnostics regulation (IVDR), scheduled to take full effect in 2022, that are to a noticeable extent changing the role of, and the attitude towards, language services in the medical sector.
Much more than the legislation before, both regulations put a good deal of emphasis on the “labeling” of medical devices and in vitro diagnostics. This term is somewhat tricky and frequently causes confusion, occasionally even among members of the regulatory profession. While “label” in the minds of most people, the word “label” will evoke an image of some kind of sticker which is put on some type of object, but it has a far wider meaning in the regulatory affairs domain and covers all sorts of textual and graphical user information related to a medical product, not only what is actually physically put on it. “Labeling” ranges from packaging to instructions for use, operator or user manuals, and, indeed, software user interfaces.
The increased focus on labeling is a result of the recognition that correct, complete, and understandable user information is an important factor in the safe and effective use of medical products, for both patients and the healthcare professionals who administer or use them. Consequently, Chapter Three of Annex One in the MDR is entitled “Requirements regarding the information supplied with the device” and gives a comprehensive list of what the labeling needs to contain and how it must be presented. As Article Two of the MDR states that “inadequacy in information supplied by the manufacturer” constitutes a “device deficiency” in an investigational product (59), and is even an “incident” with devices that are available on the market, alongside “any malfunction or deterioration in the characteristics or performance of a device…, including use-error due to ergonomic features,… and any undesirable side-effect” (64), there is little doubt that the regulators are serious about the quality of the user information, and what is presented to them by manufacturers will come under close scrutiny.
Their attention does not stop at reviewing the original (English or other) labeling, however. The MDR requires manufacturers to include the following details in their technical documentation for a product:
- “…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.” (Annex Two, Article Two. “Information to be supplied by the manufacturer.”)
In other parts of the regulation, the requirement is for “an official Union language(s) determined by the Member State in which the device is made available to the user or patient” (Article Ten, “General obligations of manufacturers,” 11). However, even more than by the explicit mention of local languages, the need to provide user information in the actual language of the user results from safety (and, eventually, liability) considerations. The paragraph quoted continues with the demand that the “particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.” Likewise, there is the requirement of the information being “written in terms readily understood by the intended user” (Annex One, Chapter Three, Article 23.1 a), and several similar provisions throughout the text.
Even with devices used solely by healthcare professionals, the assumption that technical instructions in English are “clearly comprehensible” and “readily understood” by each and every user across Europe is rather difficult to support. The slightly offhand attitude observed among some manufacturers in the past, according to which everyone, for example, in a laboratory in Europe would be able to understand English anyway, and the time and money spent on translations could be kept to an absolute minimum as they were only some bureaucratic, formal requirement, has always been risk-ridden and questionable in many ways. To give just one example, one should bear in mind that a considerable number of Eastern European EU citizens in their fifties today completed large portions of their education in Soviet times, may not have received much or any English education at school, and may not have had much reason or opportunity to study it later in any depth, yet they may very well work in responsible positions in the healthcare sectors of their countries. “Official” language requirements aside, a manufacturer may run the risk of being held liable for damages caused by a use error, for instance if an injured person can claim it had resulted from their lack of understanding foreign-language instructions properly.
What is particularly interesting in the MDR is the fact that the translation process itself is actually mentioned. As poorly translated instructions for use can potentially cause the same damage as untranslated ones that are not fully understood by the user, this may not be entirely surprising, but the context in which translation explicitly appears is quite remarkable. The “General requirements for the manufacturers” only state that the manufacturer needs to “establish, document, implement, maintain, keep up to date, and continually improve a quality management system that shall ensure compliance with this Regulation,” which includes “resource management, including selection and control of suppliers and sub-contractors” (Article Ten, Paragraph Nine); this will include the translation process, among many others.
However, Article 16, which describes “Cases in which obligations of manufacturers apply to importers, distributors or other persons,” sets out to assure that the “provision, including translation, of the information supplied by the manufacturer” does not constitute a modification of the device which could affect its regulatory compliance (Article 16, Paragraph Two). Yet, under Three and Four the distributor or importer is not only required to have a quality management system in place “that includes procedures which ensure that the translation of information is accurate and up-to-date,” but also to submit a certificate by a notified body to the health authority within 28 days before the device is put on the market. Though it is not mandatory, the compliance of a quality management system with the relevant legislation is best demonstrated by following the harmonized norm EN ISO 13485:2016, the quality management norm for manufacturers of medical devices. In practice, this provision of the MDR will most likely require any distributor or importer wanting to handle translations themselves to have an ISO 13485 certification in place which actually includes the processes around the translation activity.
Even though many people have regarded it as problematic, for a number of various reasons, manufacturers who left the translation of their product labeling to their distributors (thus letting go of any control over it) were still quite common until recently. The fact that EU legislation addresses this and demands a very high standard for this scenario seems to show that they share at least some of these concerns.
On the other hand, it also means something else — translation is officially regarded as a critical process by the regulators in the medical device and in vitro diagnostics sector, and can be certified against the ISO 13485 norm. While this certification has been happening in some EU countries for several years, certification agencies in others were reluctant to accept translation as an activity covered by the norm, and refused to certify LSPs on the grounds that it would not be within the scope of their accreditation. With the MDR in full force as of May 26th, this should not be a matter for discussion anymore.