EU Medical Device Regulation (MDR 2017/745) Enters Into Application: Language Requirements Explained
As Regulation (EU) 2017/745 (EU MDR) officially becomes applicable on May 26, 2021, medical device manufacturers face stringent mandatory translation obligations across up to 24 official EU languages for labels, IFUs, and Summaries of Safety and Clinical Performance (SSCP).
Article 10(11) and National Language Mandates Across EU Member States
On May 26, 2021, following a one-year postponement due to the pandemic, the European Union Medical Device Regulation—Regulation (EU) 2017/745 (MDR)—officially enters into application, replacing the legacy Medical Devices Directive (93/42/EEC). Under Article 10(11) of the MDR, manufacturers must supply device labels and Instructions for Use (IFUs) in the official Union language(s) determined by each Member State in which the device is made available to the user or patient. Because language content is now scrutinized prior to CE marking approval by Notified Bodies, translation can no longer be treated as a post-certification afterthought.
New Content Requirements: SSCP, Implant Cards, and EUDAMED
The MDR introduces entirely new categories of multilingual documentation. For Class III and implantable devices, Article 32 requires a Summary of Safety and Clinical Performance (SSCP) written in a way that is clear to the intended user and, where relevant, the patient—translated into the languages of all target Member States and uploaded to the EUDAMED database. Maintaining strict ISO 13485 and ISO 17100 quality management processes, locked terminology glossaries, and synchronized Translation Memories is essential for audit readiness.
Executive Takeaways for Global Enterprises
- Key Insight: EU MDR (Regulation 2017/745) applies from May 26, 2021, requiring device information in up to 24 official EU languages depending on national laws.
- Key Insight: Class III and implantable devices require a patient-accessible Summary of Safety and Clinical Performance (SSCP) validated for readability.
- Key Insight: Notified Bodies audit translation quality management procedures (ISO 13485 / ISO 17100) as part of technical documentation conformity assessment.
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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 & Medical Devices. 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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