Tips for labeling medical devices- Medical Entrepreneurship

The labeling of medical devices provides critical information about the usefulness, possible risks, and safety instructions for their use, in addition to any other information associated with a device intended for patients or healthcare professionals. And it can request a variety of formats, from brochures to user manuals or any document containing explanatory information.

Medical device labeling provides critical information on the utility, possible risks, and safety instructions for use, in addition to any other information associated with a device intended for patients or healthcare professionals. And it can request a variety of formats, from brochures to user manuals or any document containing explanatory information.

Regulatory requirements

Globally, regulators consider labeling as an integral part of the medical device itself. And international standards such as IEC 60601-1 (which establishes the general requirements for basic safety and essential performance of electro-medical equipment) consider labeling as a critical component of medical devices.

Medical device manufacturers who distribute their products abroad must be prepared to meet the different labeling requirements for medical devices around the world. All labeling contents are thoroughly examined when a healthcare product is introduced into new markets, so these documents and their medical translations must be as accurate as possible. Regulators emphasize key aspects of labeling, such as its good organization, compliance with high readability standards, highlighting important safety information, and ensuring that the content is understandable to the target audience.

Language of labeling of medical devices

Most countries or regions have their own labeling rules for medical devices.

Regulatory agencies such as the FDA do not really address the language in which medical device labeling should be presented in their directives. However, it is assumed that medical devices intended for the US market must be documented in English.

On the other hand, the EU Medical Device Regulation (MDR) provides that the Member States may require that information on medical devices be made available to the user/patient in their national languages. In particular, Annex II contains technical documentation:

INFORMATION THAT THE MANUFACTURER MUST PROVIDE

A complete set of:

-the label or labels affixed to the product and its packaging, such as unit packaging, sales packaging, and transport packaging in case of specific handling conditions, are in the languages ​​accepted in the Member States where the product is sold.

-Instructions for use in the languages ​​accepted in the Member States where the product is intended for sale.

Tips for translation and regulatory compliance

The effectiveness and safety of medical devices depend on the correct use. So, even without local and international regulatory bodies' language requirements, it makes sense to provide clear and understandable product information translated into the patient's or user's mother tongue. The precision and quality are essential requirements in professional medical translation.

These tips can help overcome multilingual problems in medical device labeling:

1: Don't assume that English language labeling can be used in other foreign countries. 

There are regulations with specific provisions that translate labels and information of use into the country's language in which medical devices are distributed mandatory. Therefore, it is advisable to consult the current legislation to avoid penalties or warning letters that may delay the launch of the product on the new market.

2: Develop common labeling for geographical areas with similar regulatory requirements. 

Instead of trying to include translation into all languages ​​in the manual/instructions for each device, more and more companies are developing region-specific labels with the same regulatory guidelines. For example, for NAFTA countries (the United States, Canada, and Mexico), where FDA-approved drugs and medical devices can be marketed, companies can develop labeling that includes only the English, French and Spanish languages.

3: Use plain language. 

Avoiding medical jargon and simply writing instructions makes it easier for patients and native users to understand the language in which they are written and facilitates translation into other required languages. Incorporate visual information: internationally recognized graphics, symbols, and icons should be used, where possible, in labeling to reduce language barriers. However, it is up to the manufacturer to ensure that the target audience adequately understands the labeling information.

4: Do not use commonly used machine translation programs. 

Errors in the translation of the instructions for the use of a medical device can cause an incorrect interpretation of the true meaning, damage people's health, and/or lead to regulatory or civil liability. Hence, it is particularly important to work with professional translation services with experience in medical translation. Automatic translations with basic tools do not accurately translate the highly technical terminology required for labeling medical devices.

5: Facilitating access to digital labeling information. 

Provided that users know clearly how and where to access the information, many regulators make it possible to find information related to the instructions for the use and safety of medical devices online. In this way, multilingual labeling can be offered without having to include bulky leaflets on the device packaging and, in turn, facilitates the updating of information.

6: Centralize the management of translation projects. 

Because translation errors can delay product approval and launch, translation management becomes an essential component of the global healthcare product distribution process. Collaboration with an experienced translation service provider that centralizes all translation projects enables consistent quality of all translations, faster turnaround times with less administrative burdens, and reduced translation costs.

7: Create a terminology base and a translation library. 

Creating a database of previously translated terms and phrases and storing translation projects in a translation library is particularly useful in this area. It allows you to consult the regulatory uses for previous translations, reuse specific terminology, and easily search a specific vocabulary.

The complex medical device labeling process is managed more efficiently when multilingual components are managed strategically from the start. Most of the companies have developed an intelligent translation platform supported by a network of translation experts in the technical industries.

Author: Vicki Lezama