How do Notified Body auditors assess translation quality?

Assessing the quality of translations in the medical device and healthcare industry is part of the processes aimed at ensuring patient safety and regulatory compliance.

Notified Bodies, through their auditors, are responsible for verifying that translations of instructions for use, labelling and marketing materials comply with the applicable regulations. But what do the regulations say? And what criteria are followed to make this assessment?

What do the regulations say about translation quality?

Both European Regulation 2017/745 on Medical Devices and European Regulation 2017/746 on In Vitro Diagnostic Medical Devices clearly establish the responsibility of distributors and importers to ensure the quality of translations.

Article 16 of both regulations specifies that these parties must have a quality management system (QMS) in place with procedures to ensure that the translated information is accurate and up-to-date.

This implies that manufacturers must also comply with these requirements, ensuring that their translation processes are aligned with regulatory requirements.

How is an accurate translation ensured?

Ensuring the accuracy of a translation is no easy task and can be achieved in different ways. However, Notified Bodies, through their audits, establish specific practices and requirements to ensure that companies comply with the regulations.

To this end, each company's Quality Management System (QMS) must include a detailed procedure describing how translations are managed. Some of the key aspects to be defined include the following:

• Will translations be managed in-house, externally or with a mixed approach?
• What quality control processes will be applied?
• Who will be responsible for producing the translations and what are their qualifications?

Outsourcing translation services

In practice, Notified Bodies consider translations carried out by external professional translation services to be more valid, provided that such services hold recognised quality certifications, such as the following:

• ISO 9001: Quality management systems
• ISO 17100: Requirements for translation services
• ISO 13485: Quality management for medical devices

These certifications ensure that translation processes comply with international quality standards and that the translators involved are qualified to work with technical and regulatory documents.

Translation certificates: traceability and transparency

To avoid problems with more demanding auditors and to ensure regulatory compliance, it is advisable for Persons Responsible for Regulatory Compliance (PRRC) to request a translation certificate. This document should be stored in the QMS and provide key information about the translation process, such as the following:

• Date of completion of the translation
• Translation project code
• Documents and languages involved
• Name of the translators and their professional qualifications

Some translation service providers, including AbroadLink, offer translation certificates at no additional cost. These electronically signed certificates can serve as evidence of regulatory compliance before auditors.

Conclusion

The assessment of translation quality by Notified Bodies is a rigorous process that requires the implementation of control procedures within the QMS of companies. The accuracy of translations is ensured by applying defined processes, using qualified translators, and validation through international certifications.

Opting for external translation services with recognised quality certifications and requesting translation certificates are recommended practices to ensure regulatory compliance and avoid potential difficulties during audits. Ultimately, translation quality affects not only regulatory compliance, but also the safety and confidence of end users of medical devices.