Technical and Regulatory Requirements for Medical Translations
Regulatory Framework and Implementation
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.
MDR Timeline
- Full implementation since May 26, 2021
- Transition provisions for existing products (Legacy Devices)
- Graduated transition periods based on risk class and existing MDD certificates
Technical Specifications under MDR
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.
Core Safety and Performance Requirements
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Risk Management under MDR
- Mandatory implementation of ISO 14971-compliant risk management
- Detailed documentation of risk-benefit analysis
- Evidence of implementation of current technical standards
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Enhanced Product Safety
- Comprehensive material testing according to current ISO standards
- Heightened biocompatibility requirements
- Thorough analysis of potential material interactions
Specific Translation Requirements under 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.
Regulatory Documentation Requirements
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Technical Documentation
- Comprehensive documentation in an EU official language
- Establishment of consistent terminology across all documents
- Complete traceability of all translation changes
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Product Information and Labeling
- Multilingual user information for all EU markets
- Target audience-specific content preparation
- Compliance with country-specific labeling regulations
tolingo's Expertise in MDR-Compliant Translation
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.
Quality Assurance in Translation Process
- ISO-certified translation processes (17100, 18587, 9001)
- Specialist translators with medical and regulatory expertise
- Continuous training in MDR environment
Technical Infrastructure
- Modern translation memory systems for consistent terminology
- Product-specific terminology databases
- Automated quality assurance tools
MDR Compliance
- Fully documented and auditable translation processes
- Validated quality control procedures
- Demonstrable compliance with all MDR requirements
Conclusion
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.