For medical device manufacturers selling products internationally, translation is much more than an administrative task. Incorrect, inconsistent or poorly controlled translations can affect regulatory compliance, product identification, traceability and, ultimately, patient safety.
While ISO 13485:2016 does not prescribe a specific translation management system, a number of its requirements can have important implications for how translated information is created, approved and controlled.
This creates an important role for specialist language service providers. Medical device manufacturers need confidence that their translation suppliers have appropriate processes, competent linguists and effective quality controls in place.
For language service providers, ISO 17100 certification can provide independent evidence that these controls are established and consistently applied.
Why are translations required for medical devices?
Within the European Union, translation requirements arise primarily from the Medical Device Regulation, Regulation (EU) 2017/745 (MDR).
The languages required will depend upon the Member State in which the medical device is being sold. This means manufacturers operating across multiple European markets can face a considerable translation project, potentially involving numerous languages and different national requirements.
The importance of translation is also reflected in guidance from the Medical Device Coordination Group. MDCG 2021-26 addresses questions concerning the requirements for instructions for use and other information accompanying medical devices.
For manufacturers, the key issue is not just that something has been translated but whether the translation process has been adequately controlled. Something that ISO 17100 addresses.
What medical device information may need translating?
Depending upon the device, intended market and applicable regulatory requirements, translation can potentially apply to several important types of information.
Labelling is an obvious example. Standardised medical device symbols, including those specified within ISO 15223-1, can reduce the amount of language-dependent information required. However, product names, warnings, instructions and other textual information may still require translation.
Instructions for Use (IFU) can be particularly important because they communicate information necessary for the safe and appropriate use of the device.
Translation requirements can also extend to the Declaration of Conformity, as well as implant cards and information supplied to patients.
Translation can even become relevant after a product has entered the market. For example, if a manufacturer needs to issue a Field Safety Notice, that information may need to be communicated rapidly and accurately across several markets.
This connects translation with the post-market and vigilance processes of the manufacturer, including ISO 13485 requirements relating to complaint handling and reporting to regulatory authorities.
Where does translation fit within ISO 13485:2016?
ISO 13485 is the internationally recognised quality management system standard specifically developed for organisations involved in medical devices.
Although ATC Certification does not provide ISO 13485 certification, our network of associates understand the standard and can support language service companies in meeting the language requirements.
Several areas of ISO 13485 can therefore have implications for translation.
| ISO 13485:2016 clause | Area | Relevance to translation |
| 4.2.3 | Medical Device File | Translated documentation may form part of the documentation maintained for the medical device |
| 4.2.4 | Control of Documents | Translated documents need appropriate document and version control |
| 7.2.3 | Communication | Relevant where information must be communicated to employees, customers or suppliers in particular languages |
| 7.4.1 / 7.4.2 | Purchasing | Relevant to the selection, specification and control of external translation providers |
| 7.4.3 | Verification of Purchased Product | Relevant to verifying that outsourced translation services meet specified requirements |
| 7.5.1 | Control of Production and Service Provision | Can apply to translated documentation and artwork used in manufacturing or supplied with the finished device |
| 7.5.8 | Identification | Translation and labelling need to preserve appropriate product identification |
| 7.5.9 | Traceability | Incorrect translated labelling could potentially affect the traceability of a device |
| 7.3 | Design and Development | Translation requirements may need to be considered as part of the outputs and controls associated with product development |
This thread running throughout the standard illustrates an important point. Translation should not sit outside the manufacturer’s quality management system as an isolated purchasing activity.
Where translated information affects regulated documentation, labelling or the safe use of a device, the translation process needs appropriate controls.
Translation as a documented process
Independent consultant, Stacey Spruels, highlights that organisations should be able to demonstrate how their translation requirements are controlled.
One approach is to establish a dedicated translation procedure. Alternatively, translation requirements can be incorporated into existing procedures, such as the manufacturer’s process for controlling labelling.
A Medical Device File may also help establish what documentation is required for a particular device. The Declaration of Conformity and applicable regulatory requirements can, in turn, help the organisation determine where translations are necessary.
A separate translation procedure is not itself a mandatory ISO 13485 requirement. However, documenting how translation is managed, including the qualifications and competencies of the linguist, can be a sensible way of demonstrating effective control where translated information is important to regulatory compliance or product safety.
Translation Service Providers are part of the supply chain
Supplier control is also an important area of consideration
When a medical device manufacturer outsources translation, the language service provider becomes part of its external supply chain.
ISO 13485 requires organisations to establish criteria for the evaluation and selection of suppliers based upon their ability to provide products or services in accordance with specified requirements. The degree of control should reflect factors including the effect of the purchased product or service on the quality of the finished medical device.
That has clear implications for translation.
A manufacturer may therefore maintain its translation provider on an Approved Suppliers Register and periodically evaluate its performance and continued suitability.
This is where ISO 17100 becomes particularly relevant.
Why ISO 17100 certification can strengthen supplier assurance
ISO 17100 is specifically designed for translation services. It establishes requirements covering the core processes, resources and other aspects necessary for delivering a quality translation service that meets applicable specifications.
For a medical device manufacturer assessing a prospective language service provider, ISO 17100 certification can therefore provide valuable supplier assurance.
It does not mean that the translation provider is ISO 13485 certified, nor does it transfer responsibility for regulatory compliance away from the medical device manufacturer.
Instead, it provides independent evidence that the translation company operates a structured translation process against an internationally recognised standard.
A medical device company may already have a sophisticated ISO 13485 quality management system, but outsourcing translations to an inadequately controlled provider can introduce weaknesses into that system. Selecting a language service provider certified to ISO 17100 provides an additional mechanism for managing that supplier risk.
For language companies wishing to work within the medical device sector, certification can therefore become a useful differentiator during supplier qualification and tendering.
An opportunity for specialist language service providers
Medical device translation is a good example of why professional translation requires more than linguistic ability or CAT/AI tools.
Language service companies operating in regulated sectors need robust processes for selecting appropriately qualified people, managing projects, controlling specifications, reviewing translations and maintaining records.
Medical device clients may increasingly want evidence that these controls exist before approving a translation company as a supplier.
ISO 17100 certification provides language service providers with a recognised way of demonstrating the maturity and control of their translation processes.
For companies already providing translations to medical device manufacturers, it can strengthen their position during supplier evaluations. For those seeking to enter the sector, certification can help demonstrate that their translation operation has been independently assessed against an international standard specifically developed for translation services.
ISO 17100 certification from ATC Certification
ATC Certification specialises in certification for the language services industry. This means our impartial auditors have language industry experience and expertise that add real value.
If your company provides medical device translations, or wants to demonstrate stronger controls to prospective clients in regulated industries, ISO 17100 certification can provide credible independent assurance of your translation processes.
If you provide translation services to medical device manufacturers, speak to ATC Certification about ISO 17100 certification and how it can support your position within regulated supply chains.