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.
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.”
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.
