The European Commission has introduced an overview regarding language requirements for medical device manufacturers through the pivotal creation of MDR and IVDR tables. These resources, developed in collaboration with Member States, aim to clarify and guide manufacturers, particularly small and medium-sized enterprises, regarding language obligations across European markets. As a professional language services provider for medical device manufacturers, we recognize the importance of these updates in ensuring regulatory compliance and effective communication.
Let’s explore how these tables offer valuable insights and how Morningside can assist manufacturers in meeting language requirements for their products.
Understanding the MDR and IVDR Tables
The MDR and IVDR tables serve as comprehensive references for manufacturers, offering an overview of language requirements for medical devices and in vitro diagnostic medical devices in each Member State. By detailing language specifications for information, instructions, and even graphic user interfaces (GUIs), these tables facilitate compliance efforts and promote accessibility for users across diverse linguistic backgrounds.
Key Benefits:
Language Requirements: includes 27 official EU member states in addition to Norway, Iceland, Lichtenstein, and Turkey.
Clarity and Accessibility: MDR and IVDR tables provide manufacturers with clear and accessible guidance on language requirements, simplifying compliance efforts and promoting transparency in regulatory obligations.
Tailored Support for SMEs: Small and medium-sized manufacturers can benefit from the tailored guidance offered by these tables, enabling them to navigate linguistic complexities and compete effectively within the European market.
Enhanced User Experience: By addressing language requirements for GUIs, the tables contribute to improving the usability of medical devices, ultimately enhancing the user experience and promoting patient safety.
Streamlined Market Entry Manufacturers can expedite market entry processes by aligning product documentation with local language requirements, leveraging opportunities for growth and expansion within Europe.
Considerations for Graphic User Interface Compliance
While MDR and IVDR do not specifically mandate language requirements for Graphic User Interface (GUI)s, certain Member States may have their own legislation and rules concerning GUIs.
Notably, information such as the “Save” function may not require translation if already provided in the language of the country where the device is used. Utilizing visual aids, such as icons, accompanied by clear instructions in the instructions for use (IFU), can further enhance user comprehension without the need for extensive translation efforts.
How Morningside Can Help
As a leading provider of language services for life sciences, including regulatory translation for medical device manufacturers, Morningside, A Questel Company, offers expertise and support to ensure compliance with language requirements. With a global reach and specialized knowledge in regulatory affairs, Morningside enables manufacturers to communicate effectively with stakeholders worldwide, promoting product success and market access.
The European Commission’s MDR and IVDR tables represent significant advancements in promoting regulatory clarity and facilitating compliance for medical device manufacturers. As manufacturers navigate the complexities of linguistic requirements, resources such as these tables and the expertise of partners like Morningside play a crucial role in ensuring effective communication and regulatory adherence. By embracing these updates and leveraging professional language services, manufacturers can confidently navigate language obligations and contribute to advancing healthcare standards across Europe.
For more information on language solutions to support compliance for medical device manufacturers, visit Morningside’s regulatory translation services page and explore the European Commission’s MDR and IVDR tables.
Madeline Sturdivant, Brand Marketing Manager at Morningside, a Questel Company, is an experienced marketing professional with five years in multiple disciplines, including digital, print, event, and strategy. She is responsible for the company's global marketing activities and managing relationships with the world's largest and most demanding healthcare, legal, and corporate organizations. Madeline's varied personal and professional interests drive her to continually expand her knowledge to benefit those around her.