The EU’s New Medical Device Regulation: What’s Language Got To Do With It?

By United Language Group

The European Union’s new Medical Device Regulation (MDR) will begin being enforced in 2020. It seems like a long way off, but it will be here sooner than we think.

The regulation, which represents a sweeping change in the way medical devices are monitored in the EU, was released in 2017 and aims to create more transparency and accessibility in the €100 billion med device market.

Namely, it outlines new rules on medical device labeling and the availability of product information. It’s no wonder then that language translation plays a big role in the MDR, and these requirements must be understood in order for global companies to become compliant before the 2020 deadline rolls around.

Here we’ll briefly go over some of the MDR’s language requirements and preview our upcoming June 13th webinar on the subject.

EUDAMED and Language Access

Under the MDR, the European Database on Medical Devices, or EUDAMED, will be created to provide the general public and medical device practitioners information on a device’s manufacturer, authorized representative and field safety corrective actions.

The idea behind implementing EUDAMED is to give consumers and medical professionals the information necessary to make informed decisions regarding specific devices.

The Medical Device Coordination Group has released guidance on the nomenclature of EUDAMED, stating that the “availability of names and descriptions in all the official EU languages is recognized as of being of high importance.”

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UDI Requirements

The MDR requires all medical devices to have a Unique Device Identification (UDI). The UDI will include a Device Identifier (DI), linked to a manufacturer and device, and a Product Identifier (PI), that identifies the unit of device production.

The UDI information will be included in the EUDAMED database and needs to be “available in all official languages of the Union,” according to the MDR. Instructions For Use (IFUs) will also be included in the EUDAMED database and need to be produced in the necessary languages based on where a device is used and sold.

Annex I of the MDR states that information on a device label and IFUs “should be provided in a human-readable format.” It also states that “the medium, format, content, legibility, and location of the label and instruction for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intender user(s).”

These instructions need to be provided in an official language of the member state where the device is made available to a user or patient.

Upcoming Webinar

Understanding new legislation is hard enough as it is, and when you add specific language requirements into the mix, things can become more challenging. However, there are ways to efficiently prepare for the upcoming regulation and the changes it will bring.  

Together with Emergo, United Language Group is hosting a free webinar on Wednesday, June 13, at 9 a.m. CST that will dive into the specific language requirements the MDR puts forth.

Presented by MDR expert and Emergo Consultant Ronald Boumans, the webinar will explore what global companies need to know about translating their device labels and provide guidance on how to execute a successful implementation.

Boumans will also be taking questions directly from attendees. Those interested in attending can register and submit their questions here.

If you’d like to view our previous webinar on the MDR and device labeling, you can access it on our Vimeo page.

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