EU Update: Overview of European Language Requirements for Medical Devices

By Elizabeth Pugh

To help medical device and IVD manufacturers understand the national language requirements under the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR), the European Commission recently published two tables on its website (January 17) with links for the relevant legal provisions for each member state.

The MDR and IVDR contain regulatory requirements for manufacturers to translate certain documentation into the official European Union language(s) (determined by the member state(s) in which the device is sold:

• Accompanying information (Ref MDR Art. 10(11) and Annex I, section 23; IVDR Art. 10(10) and Annex I, section 20)
• Implant Card (Ref MDR Art. 18(1))
• Declaration of Conformity (Ref MDR Art. 19(1); IVDR Art. 17(1)
• Field Safety Notice (Ref MDR Art. 89(8); IVDR Art. 84(8))
• Documents for conformity assessment (Ref MDR Art. 52(12); IVDR Art. 48(12))

Language requirement overview

In addition to outlining the language requirements, the guidance also provides language requirements, if applicable, to the graphic user interface (GUI). While the Regulations do not specifically impose language requirements on the GUI, several member states have national legislation about GUIs.

Concluding remarks

The Regulations allow each member state to determine the official language(s) they will require for certain documentation.

The published Overview of language requirements for manufacturers of medical devices provides manufacturers with a single resource that can be used without having to identify each member state’s requirements.