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.

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