How Localization is Important for EU MDR

When healthcare companies develop new medical devices, they have to follow an extensive list of strict regulations before launching their product. In the European Union (EU), which has 500,000 medical devices on the market, medical device businesses face an updated set of stringent requirements called the EU Medical Device Regulation (MDR). Because these rules will have a global impact on any company that plans to introduce a medical device in the EU market, the localization of medical device documentation will be a significant part of meeting the MDR protocols.

What is the EU MDR?

The EU MDR is a new set of mandates that regulates the manufacturing and distribution of medical devices across Europe, and compliance with the rules is compulsory for businesses that want to sell their medical devices there. As part of the EU MDR, medical device companies are accountable for their products for the entire lifecycle of the device. Additionally, the MDR increases requirements for device labels, including mandating that the labels are translated into the language of the country where the device will be marketed and sold.

Furthermore, the requirements provide a means of ensuring that the medical device technical information is more understandable to patients. In addition, the regulations recognize software as a medical device, which was less evident in the EU’s previous set of regulations, the Medical Devices Directive (MDD).

Localization is Vital to Meeting the Requirements

Because of the EU MDR, the translation and localization of medical device documentation are even more essential now than they were previously, especially since companies are responsible for attaining the translations, instead of depending on the EU member states to manage them.

To meet the new requirements, the following localization steps are necessary:

  • Make certain that any documents associated with medical devices are translated into all 24 official languages of the EU in the locations where the products will be distributed. These languages include Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovene, Spanish, and Swedish. For precise translations, as well as to ensure compliance, partner with a life science translation company.
  • Along with being translated, all content has to be localized to meet the needs of the region in which the product is being marketed. It is critical that every device user, including healthcare providers and patients, fully understand how to use it. As such, package inserts, user manuals, instructions for use, and other documents should be carefully tailored to suit the region, with particular attention focused on phrasing, idioms, and cultural nuances that can affect the text’s meaning.
  • Since medical devices are highly specialized products, select a life science translation services agency that has experts in the medical field available to work on the localization. A translator who is a specialist in the healthcare industry can make sure that specific terminology is both translated and localized properly, while making certain that essential information is effectively conveyed.
  • Another requirement in the MDR is that all translated data must be stored in new databases for product registration, clinical investigations, and marketing information. The database system allows consumers, medical device companies, and regulators to access and review the latest information on medical devices that are available in Europe. Because the data will be sought out by people who speak different languages, localization should be finalized before data is stored.
  • Some translations have to be completed before the product can receive the Conformité Européenne (CE) certification that verifies compliance. Whereas translations were previously required after a medical device was designated as having the CE marking, certain translations, such as instructions for use, must be submitted first. This is another important area in which a qualified localization company can be helpful, especially since accurate translations are vital to the process.

 

Quality Management is Essential for Localization

As per the MDR, businesses are required to demonstrate supply chain transparency relating to risk management and quality management. To achieve this regulation, select a life science translation company that is ISO 13485 certified. By working with a language services provider (LSP) that is certified, businesses can be assured that the LSP:

  • Has been assessed and is qualified to effectively manage risks.
  • Complies with all legal and regulatory requirements.
  • Has demonstrated that its processes consistently meet the necessary standards.
  • Guarantees that it has an excellent quality management system in place.

Projected to reach about $671 billion by 2027, the global device industry is one of the largest areas in healthcare. Because of the significant impact that one translation error can have, as well as the mandates that companies have to meet, work with a language services provider that has expertise in the industry and an understanding of the EU MDR.

Summary

Healthcare companies in the European Union are working under a new set of guidelines called the EU Medical Device Regulation. Because these rules will have a global impact on any company that plans to introduce a medical device in the EU market, the localization of medical documentation will be a significant part of meeting the MDR protocols.