Language requirements

In Sweden, there is national legislation concerning language requirements for medical devices which apply in addition to the EU regulations that apply. This means among other things that the labelling and instructions for use, and other information provided with the device, shall be in Swedish. Control panels/displays and user interfaces on devices as well as in standalone software are included in this requirement.

Devices according to MDR and IVDR

For medical devices complying with one of the EU Regulations 2017/745 (MDR) or 2017/746 (IVDR), the language requirements are set out in a Swedish national regulation (SFS 2021:631) laid down according to the provisions in MDR and IVDR for national language requirements.

A user of medical devices shall have access to information in Swedish, while information that is required to be provided to the Swedish Medical Products Agency (Swedish MPA) shall be in either Swedish or English.

Manufacturers and/or other economic operators that make MDR and/or IVDR devices available on the Swedish market shall ensure that:

• The labelling and instructions for use, and other information provided with the device, are in Swedish. This also includes control panels/displays and user interfaces on devices, as well as in standalone software.
• The EU declaration of conformity shall be either in Swedish or English.

• The manufacturer’s safety information to users, the “Field safety notices” (FSN) to the market shall be in Swedish.
• The information on implants to be provided by the manufacturer pursuant to Article 18(1) of the MDR shall be in Swedish. However, the information on an “implant card” that comes with the device may be in English.
• Information and documentation necessary to prove the device’s compliance with the requirements (e.g. technical documentation/file) to be submitted to the Swedish MPA upon request shall be in either Swedish or English.
• The application for designation as a notified body and the reports drawn up when assessing the application shall be in either Swedish or English.
• Certificates of conformity issued by notified bodies in Sweden shall be in either Swedish or English.
• Documentation that is part of the conformity assessment of the notified body in Sweden, and can be requested by the Swedish MPA, shall be in Swedish or a language approved by the notified body.
• The summary of a clinical trial that are required to be submitted as part of the application (in accordance with section 3.1.5 of Chapter II of Annex XV to the MDR) shall be in Swedish.

Devices compliant with the Directives on Medical Devices

For devices complying with the requirements of one of Directives 93/42/EEC (MDD), 90/385/EEC (AIMDD) or 98/79/EC (IVDD), the language requirement in Swedish continues to be applicable. The requirement that the device’s labelling and instructions for use be in Swedish applies irrespective of whether the device is intended for professional use or not. The language requirements are set out in the article 4 § of the Swedish MPA’s regulations (LVFS 2003:11, LVFS 2001:5 and LVFS 2001:7). Refer to the table below for the link between the European directives and the Swedish regulations.

Language requirements in other member states

The European commission has compiled tables of the language requirements that are applicable in the member states of the EU/EEA. The tables for MDR and IVDR are available on the website of the European Commission.