EU MDR (European Medical Device Regulation)
The EU MDR (Regulation (EU) 2017/745) is the European Medical Device Regulation that has been fully applicable since May 2021, replacing the former Directive 93/42/EEC (MDD). It establishes comprehensive requirements for the safety, performance, clinical evaluation, and surveillance of medical devices. The regulation applies directly in all EU Member States and tightens requirements for labelling, traceability, and clinical evidence, among other areas.
The EU MDR is the central regulatory framework that defines translation obligations for IFUs. Every manufacturer seeking to market medical devices in the EU must comply with the linguistic requirements of this regulation.
Frequently Asked Questions
What translation requirements does the EU MDR impose on manufacturers?+
EU MDR Article 10(11) requires that all information provided to the user – including instructions for use and labelling – must be available in the official language of the respective Member State. This also applies to electronic IFUs (eIFUs). Manufacturers must ensure the linguistic correctness and technical accuracy of all translations.