What are the rules?

Importing and distributing medical devices to countries around the world is subject to strict approval processes and compliance measures. Compliance is how medical device companies insulate their patients and business from risk. While internationally recognised systems are helpful in meeting many compliance needs for manufacturers, it is important to note that no single system is universally applicable. Due to varying regulatory requirements between countries, parties cannot rely on generic guidelines being suitable for a specific market. This contrasts with the situation for pharmaceuticals, where standard templates and the structured Common Technical Document apply for major global markets and simplify the translation process.

The rules keep on changing

From market to market, change is the only constant. The past year or so has been dominated by changes resulting from EU MDR, and indeed, implementation delays. In the past, medical devices needed only to provide translations after a device earned the CE mark. This is changing in an effort to improve patient safety, and many documents required for the new approval process must now be translated into all 24 official EU languages prior to that approval process. This means that translation enters the product development process earlier, and translation partners may find it easier to involve themselves upstream. Specifics of language requirements for each country are now available. That’s the new EU regulation. But the EU is only one part of the large global market.

Good practices (GxP) guidelines by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Medical Device Regulators Forum (IMDRF) documents are broadly applicable. ISO 14155: 2020 is the standard relating to Good Clinical Practice for medical devices. FDA requirements such as 21 CFR Parts 11 and 820 apply in the United States. Add to the mix privacy-related regulations such as the US HIPAA and EU GDPR. Other smaller markets have their own regulations. The UK, post-Brexit, will implement its own device regulation but has delayed implementation and is extending acceptance of CE marks at this time. Harmonisation efforts have had success but will not replace each locale’s regulation.

Regular referees

Most readers will be familiar with ISO 9001, a generic quality management system standard that can apply to any organisation. ISO 13485:2016, “Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes,” has a stronger focus on medical device safety, traceability, and risk management. Many translation buyers will audit providers to the standards of ISO 13485 as they relate to service providers. We now also see reference made to ISO 14971.10 “Medical devices, Application of Risk Management to Medical Devices,” which goes even further to help companies systemat ically implement best practices that reduce risk.

Who is playing?

Who are the clients? Manufacturers, distributors, and other interested parties, of course. And who is translating? From small buyers using individual freelancers to translate one language pair to global giants with multimillion annual spends in programmes handled internally or through one or more large language service providers (LSPs), there’s no one answer. What is common to all, though?

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