Dr. D is going to switch things up this week and talk about a requirement that should be deemed mission-critical in the European Union but obviously a non-issue in the United States, Australia, and other countries willing to accept English only on their labeling. If you guessed that the doctor is going to talk about the translation of labeling, then you would be correct.

For you upstart and wannabe “parvenus” (look-it-up) out there, understanding the nuances associated with the translation of medical device labeling, instructions for use, and text being placed onto cartons and pouches is an extremely important activity that is typically outsourced. There are many capable third-party translation services, such as IDEM Translations, (no Dr. D is not a paid spokesperson for this entity) that are available to provide accurate translations, critical to support the device industry. In fact, there is even a European standard that governs translation services EN 15038:2006. Marry EN 15038:2006 with ISO 15223-1:2012 (symbols) and all labeling bases in the EU are for the most part covered. That being said, the doctor will jump into EN 15038 requirements for this week’s guidance. Enjoy.

EN 15038:2006

Dr. D is well aware that many American-based devices companies are linguistically challenged when it comes to languages other than English, including the Irish and UK versions of English. However, letting your next door neighbor translate marketing material because Spanish is their native tongue is just insane, literally and linguistically. Even worse, rely on Google translate and see how fast the regulators start lighting up your organization’s telephones. Please save yourselves some regulatory headaches and select a translation provider that retains an ISO 9001 or ISO 13485 certification, with an EN 15038:2006 accreditation. Otherwise, trust doctor D when he says; “You will be sorry!” Besides, if an IFU or other piece of product labeling has a translation rampant with errors, a market withdraw will probably be in your organization’s future. Can you say RECALL (the doctor’s favorite six-letter word)?

EN 15038 requires translation services providers to:

• Have a documented procedure that delineates requirements for selecting individuals with the proper translation skills; 
• Define competencies required for translators, revisers, and reviewers; 
• Identify and procure necessary resources to support the translation business; 
• Have an appropriate QMS in place to support business operations; 
• Have resources in place for sustaining effective project management, including procedures to facilitate the effective management of projects; 
• Have written agreements in place with clients; 
• Maintain appropriate administrative tools to ensure projects are properly managed; 
• Apply tools similar to style guides in support of translation projects; and 
• Ensure value-added processes provided by the service provider receive the same oversight as the actual translation processes. 

One final point that needs to be made is the importance of the QMS. Remember EN 15038 is not a QMS standard. It is a standard that defines requirements for translation services. It is imperative that the translation service provider have a QMS that has been certificated by a recognized registrar or notified body such as TUV-R, TUV-SUD, NSAI, BSI, UL, NSAI, SGS, or other such reputable firms.

Takeaways

For this week’s guidance, the doctor will leave the readers with just one takeaway. Having accurate translations should be deemed mission-critical for device manufacturers wishing to enter product into commerce outside of the United States. The doctor strongly suggests selecting a translation service provider that has been accredited to EN 15038:2006. If you need something translated into Spanish, you can send it to Dr. D; however, everyone knows that the doctor’s composition skills in Spanish are suspect. Sí, señoras y señores?

In closing, Saludos y gracias for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.

References: 

1. EN 15038:2006 (2006, January). Translation services – service requirements. Brussels, Belgium. 
2. Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
3. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.