Notification
In accordance with the Regulation No. 461 of the Cabinet of Ministers of Latvia Medical Devices Regulation Article No. 9 and Regulation No. 582 In vitro Diagnostic Medical Devices Regulation Article No.8 persons who take up a placing on the market within the territory of the Republic of Latvia of class IIa, class IIb, class III medical devices as well as Class B, C, D, List A, List B and self-test in vitro diagnostic medical devices, have to submit to the State Agency of Medicines the Statement Form and copies of EC (EU) Declaration of Conformity and CE certificates (issued by a notify body).
It is possible to submit a notification form electronically in the information system LATMED.
The notification of class I medical devices and Class A, other in vitro diagnostic medical devices is not mandatory.
There are no fees for notification and registering medical devices at the national medical devices database.
Language requirements
According to the Regulation No. 461 of the Cabinet of Ministers of the Republic of Latvia Medical Devices Regulation, adopted on August 15, 2023 and to the Regulation No. 582 In vitro Diagnostic Medical Devices Regulation, adopted on October 10, 2023, the information supplied to users and patients in accordance with Section 23 of Annex 1 of the Regulation 2017/745 or Section 20 of Annex 1 of the in Regulation 2017/746 shall be in the national language. This information may not be provided in the national language if the medical device is intended to be used only in a medical facility and intended to be used only by suitably qualified and trained medical personnel, provided the consent of a specific medical institution regarding the use of foreign language in the documentation of medical device.
The Official Language Law lies down that for any imported devices, the labelling, instructions for use, guarantee documents or technical certificate which includes information in a foreign language, shall have attached thereto a translation of such information in Latvian language. If a foreign language is used concurrently with Latvian language, the text in Latvian language shall be placed in primary position, and it may not, in its form or contents, be smaller or narrower than the text in the foreign language.
