Passing the painstaking standards for multilingual medical device labeling is tough. Achieving this requires accurate translation, localization, testing, and validation. The key, of course, is advanced planning and thorough preparation.
Translation for medical device content is particularly more demanding than it is for other sectors. It doesn’t just require quality assurance review to make sure the translation is accurate and properly localized. It also adds an extra, very crucial step: in-country review (ICR).
While ICR is not mandated by MDR/IVDR or by any other official directive, it has become a best practice used by medical device companies in order to ensure the quality of translations.
Many manufacturers have their own in-country reviewers. These individuals are usually internal employees from the target country such as product managers, application specialists, sales, and marketing people. However, the lack of suitable resources and the fact that in-country reviewers do ICR as a side job to their main activities turn the ICR process often into an endless story, creating bottlenecks and putting even product release dates at risk.
Therefore, another approach is to outsource ICR to third-party companies to handle medical ICR using qualified reviewers with the necessary subject matter expertise (SME) in the respective medial vertical.
How to Review?
First, it is essential to define the process and tool used in order to do ICR. A process based on PDFs with annotations can increase the noise and overall time needed, adding some risk of introducing errors and not resolving issues. A more systemized approach using a tool environment, either a translation management system (TMS) or a review system, connected with approved terminology, can significantly improve and streamline the ICR process.
It is also very important to get the in-country reviewers properly trained, either a client’s reviewers or the SME reviewers in an outsourced model.
This training should include the overall concept of translation. This is important, so the reviewers know what impact unnecessary changes may have on the quality and the consistency of the translated content as well as on the translation assets (translation memory and terminology) and the overall translation cost.
And last but not least, in-country reviewers should also be trained on what to correct and what not to correct, in order to focus on the scientific correctness and translation accuracy without introducing inconsistencies and even errors and without deviating from the source content, which is critical in the regulated medical device industry.
Are There Alternatives to ICR?
As mentioned above, MDR and IVDR are not mandating ICR but only refer to a quality management system with processes in place that ensure the accuracy of translations. Because of the bottleneck ICR often causes, more and more medical device companies are therefore looking for ways to eliminate the ICR partially or entirely from their process and still be compliant with their internal quality and regulatory policies.
In order to do that, specific requirements need to be in place:
- LSP certification. Following the wording of the new medical device and IVD regulation, the language service provider (LSP) should be certified according to the ISO 17100 standard and follow a quality procedure that is according to the ISO 13485 standard for medical device companies, as the LSP is ultimately involved in the life cycle of the medical device.
- A Certificate of Accuracy issued by an LSP certified according to ISO 17100 and ISO 13485 standards. This certificate can replace any sign-off form from an in-country reviewer.
- Subject matter expert (SME) translators. By eliminating the ICR, the reviewer’s qualification requirements such as product knowledge and scientific background must be covered during the translation phase, therefore it is recommended to work with SME translators with a scientific background, working experience in hospitals or laboratories, and good understanding of the medical devices and instruments. Furthermore, onsite or online training for products and especially new products is a very good practice that helps SME translators become more familiar with what they must translate.
- Terminology, TM, and other translation assets. It is necessary to have a solid and well-structured terminology management (TM) process in place that involves the client, the LSP, and the reviewer, as using an application specialist or a product manager in the country to support reviewing, validating, and approving terminology makes much more sense than having them do the ICR. A solid term base with corporate and product terminology, including product names etc., validated and approved prior to the translation is key to a successful handling and use of the terminology.
Other aspects that need to be taken into consideration are the TM status and whether the TM regarding approved terminology is up to date. It does not help to have an approved term base in place when the terminology used in the TM is not in sync. There may be a need to clean up the translation memory in order to have all translation assets (term base and TM) in good quality.
Medical Device Companies Should Plan Accordingly
There are direct consequences for substandard translation or inadequate localization: market delays, lost revenues, additional work, and higher costs. Before you translate a single word, review all the requirements and plan accordingly.