Notification
In accordance with the Regulations No. 689 of the Cabinet of Ministers of Latvia , adopted November 28, 2017 “Procedures for Registration, Conformity Assessment, Distribution, Operation and Technical Supervision of Medical Devices” article No. 26 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, active implantable medical devices and IVD medical devices referred to in List A and List B, as well as medical devices for self-testing have to submit to the State Agency of Medicines the Statement Form and copies of EC 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, and other IVD 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. 689 of the Cabinet of Ministers of the Republic of Latvia "Procedure for Registration, Assessment, Distribution, Exploitation and Technical Supervision of Medical Devices" adopted on 28 November 2017, information, which is available to the user and the patient so that the medical device can be used in accordance with the intended purpose, shall be in the official language.
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.
