Exemption from language requirements for instructions for use of medical devices intended for use by the general public.

According to Regulation No. 630/2022, information and instructions for use intended for the general public must be in Icelandic. However, instructions for use for medical devices in risk classes I and IIa may be in English or another Nordic language, excluding Finnish.

It is possible to apply to the Icelandic Medicines Agency for an exemption from the language requirements for instructions for use of medical devices in risk classes IIb and III.

Generally, applications are processed within two weeks. Please make an effort to submit

applications in a timely manner. Indicate here if you are requesting expedited processing,

including the reason and the desired deadline for the processing. During the review, the

Medicines Agency will assess requests for timelines and prioritisation of tasks.

Delivery

Next month

Cost

The Icelandic Medicines Agency (IMA) collects a fee for the evaluation of an application for the use of a medical device that does not meet quality and safety requirements for public health or for the safety of the patient(s). The fee for the evaluation of an application for exemption from the requirements is in accordance with Article 3 (3.3) of the tariff for the IMA‘s surveillance of medical equipment. If the application is approved, a certificate is issued as confirmation, and a fee for issuing the certificate is charged in accordance with item 1.3 of Article 1 of the same fee schedule.

Gjaldskra-laekningataekja-nr.-1555-2023-heimasida-17.1.2024.pdf