Regulatory requirements

Providing user or patient information in the target language is a legal requirement in most countries.

In the European Union, these requirements are based on the new EU regulations 2017/745 Medical Device Regulation (MDR) and 2017/746 In-Vitro Diagnostics Regulation (IVDR). In May 2017, these regulations replaced the previously applicable EU directives 93/42/EEC Medical Device Directive (MDD), 90/385/EEC Active Implantable Medical Devices Directive (AIMDD) and 98/79/EG In Vitro Diagnostic Directive (IVDD) and must be implemented by 26 May 2021 (MDR) and 26 May 2022 (IVDR) respectively.

As user information is considered under the legislation to form part of a medicinal product or medical device, the translation of safety-relevant patient information, such as package inserts or user guides, is subject to particularly rigorous standards of linguistic quality and also requires the use of processes that ensure transparency and traceability—entirely in keeping with the requirements that apply to the process of manufacturing the medical or pharmaceutical product itself. This is why we are certified under ISO 13485, the quality management standard for medical product manufacturers, in addition to our certification under the ISO 17100 translation standard. This means that we insist not only on highly qualified translators but also on clearly defined and documented processes, based on ISO 14971 risk analysis and risk management criteria and defined in binding Standard Operating Procedures (SOPs).