Introduction In an ever-evolving landscape of medical device regulation, understanding and adhering to the varying language requirements across Europe is crucial for manufacturers. The Medical Device Coordination Group (MDCG) released a comprehensive guidance document on 17 January 2024, aimed at clarifying these requirements. This document is particularly relevant for regulatory affairs professionals and manufacturers, including those in small and medium-sized enterprises.
Implications for Manufacturers The Regulation (EU) 2017/745 on medical devices (MDR) allows EU Member States to set their own language requirements for manufacturers regarding the information that accompanies a medical device. The specific provisions vary by country, and the Member States are not required to mandate a specific language. They are, however, encouraged to consider accepting information in a common language like English, especially for devices intended for professional use, as long as it doesn't compromise safety. The provided information is based on a consultation with the Medical Device Coordination Group (MDCG) in October 2023.
Manufacturers need to be aware of these requirements to ensure market access and regulatory compliance. This is not only a regulatory mandate but also a critical aspect of ensuring patient safety and effective device usage.
Remember It's important to note that the Commission services do not guarantee the accuracy of this information. Ultimately, the specific provisions of the MDR and the national laws of the Member States regarding language requirements are authoritative and take precedence over this overview.
Conclusion The MDCG's 2024 guidance document serves as an invaluable resource for navigating the complex linguistic landscape of the European medical device market. Manufacturers and regulatory professionals must stay informed and compliant with these guidelines to successfully distribute their products and ensure patient safety across diverse European communities.
