A national legislation, regulation 630/2022, concerning language requirements for medical devices complies with EU Regulations 2017/745 (MDR) and 2017/746 (IVDR).
Instructions for use that are provided to medical devices intended for use by healthcare professionals
Medical devices instructions for use intended for use by healthcare professionals may be published in English, or a Nordic language other than Finnish.
Instructions for use that are provided to medical devices intended for use by the general public
The general rule is that instructions for use intended for the general public shall be in Icelandic.
In the case of medical devices in risk classes I and IIa, the instructions for use may be in English or a Nordic language other than Finnish.
According to national regulation 630/2022 the Icelandic Medicines Agency can grant an exemption from the language requirements for devices in risk classes IIb and III. A list of medical devices that have been granted this exemption has been published.
Note that if types or categories of medical devices are included in that list, instructions for use shall be in English or a Nordic language other than Finnish.
An application for exemption from language requirement should be sent to [email protected] The request assessment is based on factors such as risk, public safety and user group.