The Medical Device Regulation (MDR, 2017/745) represents a fundamental shift in European medical device regulation. The General Safety and Performance Requirements (GSPR) form the cornerstone of this regulatory framework, superseding the Essential Requirements of the previous Medical Device Directive (MDD, 93/42/EEC). This transformation has far-reaching implications for the documentation and translation of medical devices.
The MDR sets particularly stringent requirements for the quality and availability of translations in technical documentation and user information. The regulation demands not only precise content translation but also consideration of cultural and regulatory specificities in respective target markets. This requires a deep understanding of both medical terminology and regulatory requirements across EU member states.
The technical requirements of the MDR directly impact translation work. Precise and technically accurate translations are essential for the safety and compliance of medical devices. tolingo has specialized in meeting these challenges and offers tailored solutions for the complex requirements of the MDR.
The MDR imposes specific requirements for translating medical documentation. This involves not just language transfer but comprehensive quality management in the translation process. tolingo has developed specialized processes that meet the high standards of the MDR.
As a specialized translation service provider, tolingo possesses extensive experience in implementing MDR requirements. Our processes and quality standards are specifically tailored to the needs of the medical technology industry.
The MDR introduces new and complex requirements for the translation of medical documentation. Precise and professional translation is not only a regulatory requirement but also a crucial factor for patient safety and market access. With tolingo as an experienced partner, medical device manufacturers can efficiently and compliantly master these challenges.
Our specialized translation teams understand the specific requirements of the MDR and ensure compliant implementation of all linguistic and regulatory requirements through established quality processes and state-of-the-art technology. In this way, we support our clients not only in complying with MDR regulations but also contribute to the safety and effectiveness of their medical devices.
Learn more about how tolingo can support you in MDR-compliant translation of your medical device documentation.