Medical Devices: Solutions for EU MDR and IVDR Compliance

SDL addresses the content, localization, language and product text needs of 19 of the world’s top 20 medical device companies. Our extensive experience tells us that compliance for upcoming EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) doesn’t have to be painful—and that translation and content management doesn’t need to complicate your compliance objectives.

EU MDR applies to medical device manufacturers, distributors and importers and extends its requirements beyond that of ISO 13485:2016. 

Are you prepared for MDR?

EU MDR & IVDR Solutions
Technical Documentation

Technical Documentation Authoring, Management and Translation

EU MDR/IVDR, Chapter V Classification and Conformity, requires all documentation to be available the official languages of the Member States. This documentation includes technical documentation, audit assessment and inspection reports. 

SDL Tridion Docs support technical documentation authoring, content management and language requirements, through: 

Post-Market Surveillance

Post-Market Surveillance

MDR chapter VII indicates that manufacturers must ensure that field safety corrective actions are brought to the attention of the medical device users using a field safety notice. SDL helps by providing: 

  • Translations for field safety notices in the official EU language or languages determined by the Member States. 
  • Workflow solutions that work together with your business processes.
Distributor and Importer Enablement

Distributor and Importer Enablement

To comply with EU MDR Article 16, SDL aids distributors and importers by: 

  • Ensuring product-related translations are accurate and up-to-date. 
  • Accurately translating product labels and instructions for use.
Clinical Investigation Plan

Clinical Investigation Plan

MDR 5, Annex XV, states that the overall summary of clinical investigation should be in the official language determined by the Member State. SDL provides: 

  • Clinical and medical linguist expertise to translate and deliver clinical investigation plan summaries in the required Member State languages.
Medical Device Software Localization and Testing

Medical Device Software Localization and Testing

SDL’s extensive specialized localization testing services including functional, linguistic and international testing. 

SDL Testing Services provide critical benefits to your organization, delivering an essential last line of defense before you release medical products to your global marketplace.