EU-MDR: Deadline and Requirments
Many companies are still trying to make sense of their new obligations under the European Regulations concerning medical devices and in-vitro medical devices. In 2017, the European Union (EU) released a list of requirements for developing, producing, and commercializing medical devices. The EU will start enforcing the Medical Device Regulations (MDR) in May 2020.
The goal of the new regulations is threefold: (1) to modernize the regulations, (2) to better address risk management, and (3) to ensure the ongoing safety of medical devices sold in the EU. Whether you are headquartered in the European Union or simply export to an EU country, your business must meet the requirements outlined by these regulations.
MDR Translation Requirements
The MDR requires that all medical devices be registered with The European Database on Medical Devices (EUDAMED). Some of the essential information needed for registering medical devices includes a Unique Device Identification (UDI) and translations of Instructions For Use (IFU) in the languages of intended country distribution.
The MDR will require that medical device content be translated into the official language of each EU member state where the product will be marketed (up to 24 official languages for products marketed throughout the EU). Much of the content to be translated can be classified as either “instructions for use” (IFU) or patient information (patient manuals). In addition to the appropriate translations, the content for commercial products must be written in layperson terms.
The legislation will not only affect technical documentation but also labels on medical devices and packaging: new UDI requirements will impact labeling layout, making it crucial that designs take localized text expansion into account. Reclassifications of products might cause changes to the technical documentation, which will need to be translated to the languages of your target markets. Furthermore, applications for clinical investigation and analyses of serious incidents may also require translation.
Language services providers, like Powerling, understand the new requirements, will be able to proactively support you in achieving timely compliance with the new regulation. We have a solid background in medical device translations and can help you address the challenges of the IFUs and the new UDI labeling requirements.
If you would like to learn more, contact us at firstname.lastname@example.org or at +1 857 400 8723!