Medical Device Labeling: The Unexpected Adventure in Fine Print and Frustration

A few weeks ago I explained to my teammates my dislike for labeling topics in medical devices. My colleagues found it so interesting that they suggested sharing my opinion on labeling with the world, so here it goes.

When I first started working on labeling regulations for medical devices, I thought it would be a simple project. The regulations define the content that must be included on the medical device or the instructions for use (IFU). Standards like IEC 60601 – Medical electrical equipment standard impose additional requirements. Nothing to worry about – kind of like IKEA instructions, except instead of assembling a coffee table you’re trying to prevent people from accidentally misusing a medical device that could affect patient, user, or third-party safety.

Taking a look in the Medical Device Regulation (MDR) one finds the first requirements on labeling in article 7. The requirements of this article are understandable: the labeling shall not provide information that may mislead the user regarding the intended use and functionality of the medical device but inform the user of risks associated with the medical device. Although the requirements are actually quite understandable, this is where the first hurdles arise in implementation.

Where do you draw the line? Extent of Medical Device Labeling Detail

We all heard the horrific stories in which an animal was dried in a microwave and unfortunately died. Since then there is supposed to be a safety hint in the microwave’s IFU stating that animals should not be microwaved (I never verified that claim). But is this the level regulators expect, given that medical devices are used by healthcare professionals?

Usability engineering provides the answer to this question by considering the intended use, the anticipated users, the disease/injury to be diagnosed or treated, and the usage environment. And if the usability engineers do their homework, they might discover that medical devices are not only used by medical professionals, but also by laypeople. A blood pressure monitor can be used by a tech-savvy teenager just as easily as by his/her 90-year-old grandmother. The safety hints in the IFU should therefore address both. This makes it all the more important to include meaningful safety hints in the IFU and not to let the IFU serve as a dumping ground for risk control measures that can not be implemented into the medical device by the planned release date.

Lost in Translation: The Trials of Medical Device IFU Language Requirements

Let’s move on to the requirements, which takes us to translations. Also a straight forward topic, right? That’s until you have to validate a Chinese translation. You start looking for a translation agency that ideally translates into all required languages ​​and has a technical background. If you want to keep the finance department happy, the translation agency will even work for free (as if). Once you find a translation service provider, you’ll quickly learn that Portuguese in Portugal is not the same as in Brazil, Norwegian differs in different parts of the country, and the claim that Austrian German is the same as German German could lead to the ambassadors of both countries being summoned.

Once you receive the required translations, you have to validate them. Unfortunately, it’s not enough to simply certify that something that looks Chinese is Chinese. Since many companies now operate internationally, there might be someone who can validate one or another translation. If these resources aren’t available, some manufacturers try to perform the validation using Google Translate. But wait, wasn’t there something in ISO 13485 about computerized systems that influence product quality and the need to validate these computerized systems?

By now we know that translations are annoying and we’re looking for a solution. This is where we come across the guidance on MDR/IVDR language requirements for manufacturers and quickly realize that many European countries would accept English if the medical device is used by healthcare professionals. However, anyone who thinks they’re off the hook and can get by with the English version is mistaken. Many of your customers will insist on labels and IFUs in their national language. So back to the beginnings and choosing the right translation service. Fortunately, some translation agencies are certified for ISO 9001 and ISO 13485. Additionally, a suitable translation agency holds a EC/IEEE 82079‑1 and/or ISO 17100:2015 certificate.