EU In Vitro Diagnostic Regulation (IVDR 2017/746) Applies Today: Managing Multilingual IFUs
On May 26, 2022, Regulation (EU) 2017/746 on in vitro diagnostic medical devices officially enters into application across the European Union, introducing strict national language requirements for assay labels, IFUs, and Summaries of Safety and Performance (SSP).
Navigating the May 26, 2022 IVDR Milestone and Regulation (EU) 2022/112
Today, May 26, 2022, marks the official Date of Application of the EU In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation EU 2017/746). While Amending Regulation (EU) 2022/112—adopted in January 2022 to prevent supply shortages of essential laboratory tests—granted staggered transitional deadlines for legacy devices (extending to May 2025 for high-risk Class D devices, May 2026 for Class C, and May 2027 for Class B and sterile Class A), all new IVDs and non-sterile Class A devices placed on the EU market must comply immediately with full IVDR requirements.
Summaries of Safety and Performance (SSP) and Analytical Terminology
For Class C and Class D diagnostic devices, Article 29 of the IVDR requires manufacturers to draw up a Summary of Safety and Performance (SSP) validated by a Notified Body and made publicly available via EUDAMED in the official languages required by target Member States. Translating IVD documentation demands specialized biochemical and molecular diagnostics expertise—accurately rendering analytical sensitivity, limit of detection (LoD), cross-reactivity tables, and specimen stability warnings across up to 24 EU languages.
Executive Takeaways for Global Enterprises
- Key Insight: Regulation (EU) 2017/746 (IVDR) applies from May 26, 2022, with staggered transition windows under Regulation (EU) 2022/112 for legacy assays.
- Key Insight: Class C and D devices require a Notified Body-validated Summary of Safety and Performance (SSP) translated for EU markets.
- Key Insight: ISO 13485 and ISO 17100 certified translation workflows protect diagnostic manufacturers during Notified Body technical file audits.
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Editorial & Copyright Attribution Note: This industry analysis has been independently synthesized and adapted by Alphatrad’s editorial team based on verified regulatory documentation and industry research originally published by European Commission – Public Health. For the original publication and primary documentation, please consult:
Source: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
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