The European Union Medical Devices Regulation (EU MDR) is now in effect. Manufacturers will need to comply with more stringent requirements for medical device labeling and instructions for use (IFUs). Medical device content must be translated into the official language(s) of each EU member state where the product is sold. In addition, certain content in every language must be written at a level that an average person (not necessarily a medical professional) can understand. A Summary of Safety and Clinical Performance (SSCP) will also require translation. In short, changes in translation for EU MDR compliance will soon take effect for sellers of medical devices in European Union member states.
Devices certified under the previous regulation (Medical Device Directive) have a grace period before they need to comply with the EU MDR. These devices have until their license expiration date to comply with the new regulations. For some companies, that could be as late as 2024. EU MDR was initially slated to go into effect in May 2020, but in light of disruptions brought by the COVID-19 pandemic, the EU postponed it for a year. Similar regulations for in-vitro diagnostics (EU IVDR) will take effect in May 2022.
Many of our clients have already taken steps toward meeting the EU MDR labeling requirements. As we’ve written elsewhere, translating patient-facing medical content brings challenges. However, advance preparation by the client speeds the process and ensures the translation quality required by the EU MDR. Here are some issues to keep in mind when planning for translation for EU MDR compliance:
The EU MDR requires alignment of meaning across all labeling content, including IFUs, patient manuals, and package labeling. A rigorous technical writing process on the part of the client should ensure consistency of the source content. Some segments of text might be repeated verbatim across all three. The translation workflows of established translation agencies should align well with a systematic source text writing process.
Your language services partner will launch the project by creating a comprehensive glossary of terms and their validated translations. The team will then load the source terms and their target translations – the “termbase” –into their computer-assisted translation (CAT tools). While the translator works, constant access to the term base ensures consistency.
A second feature of CAT tools is their treatment of repetitive text. After the team uploads a set of documents, the tool breaks them down into segments. If a segment is repeated verbatim within a document, or across a set of documents, the translator only needs to translate it once. The tool auto-fills the translation wherever the segment appears. This also ensures consistency, and when there is a lot of repeated text, it saves time and money for the client.
Finally, at the conclusion of a project, the tool retains a “translation memory” (TM) of all source-target pairs. When a document is updated, the TM flags the changes and auto-fills all the unchanged segments of the document.
Best practice: Create consistent and unambiguous source texts
Use the same language service partner (LSP) for all of the content for a particular project and language.
It can be hard for writers of specialized medical texts to create simple, accessible, yet accurate prose. The same applies to translators. Advise your language services partner of the style of communication required by the EU MDR for each type of content. If the translator does not understand your needs, or cannot meet them, your content may not fulfill the requirement that it be “understandable to a layperson.”
Secondly, keep in mind that several EU member nations speak common languages, such as French and German. Member nations with more than one official language will require the patient-facing content to be provided in each language. If you plan to market in Belgium, France, and Switzerland, for example, you will require French content for each. However, when writing in a “layperson’s” register, certain terms may have different colloquial meanings. Ensure that your language partner knows which variants of French or German you need.
Best practice: Be clear with your language service provider about your needs.
Don’t overlook the possibility of cultural and linguistic differences for speakers of the same language in different regions.
In any medical translation, accuracy is of paramount concern. Choose an ISO 17100-certified translation partner to do the work. The certification demonstrates strict compliance with global standards for ensuring translation accuracy, from vetting and testing linguists to QA procedures.
For medical content, or any “high risk” content, specific linguistic validation steps are required. You should ask your language service partner to perform a back translation. After translation, proofreading, and QA, the text should be translated “back” into the source language by an independent translator with no knowledge of the original source. We then compare the source document and back translation to check equivalency of meaning. Evidence of having completed back translation may be part of your submission for regulatory approval.
Other linguistic validation steps might be required. You will find several options along the linguistic validation spectrum. You might require two forward translations followed by a reconciliation step during which you choose the “best of both.” Or you might validate a single forward translation with two back translations. In addition to documentation of linguistic validation, your language service partner should be able to provide an “affidavit of accuracy,” affirming that qualified translators performed the translation.
Best practice: Choose an ISO 17100-certified language partner.
Make sure you understand what documentation you will need to demonstrate quality assurance on the part of the translation team.
When sourcing translation for EU MDR compliance, work with a language services partner who understands the process. Yes, the translation process might seem complex. However, in the future when you need to update your multilingual content, much of the groundwork will already have been completed.