[EU] EU Update: Overview of European Language Requirements for Medical Devices

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))

 

EU Update: Overview of European Language Requirements for Medical Devices | Emergo by UL

EU Update: Overview of European Language Requirements for Medical Devices