Ministru kabineta noteikumi Nr. 461

Latvia’s core medical device instrument: Ministru kabineta 2023. gada 15. augusta noteikumi Nr. 461, adopted 15 August 2023, in force since 23 August 2023, published in Latvijas Vēstnesis 161 of 22 August 2023. Issued under Article 34(2), points 2, 3, 4 and 5 of the Medical Treatment Law and Article 7(1) and (2) of the Conformity Assessment Law. In nine chapters: general provisions, including the essential requirements and the definitional scope; the device notification procedure; the rights and duties of State administrative institutions; the procedure for entering information on manufacturers, their devices and distributors into the LATMED database; the issue of an authorisation to place a device on the market; distribution, use and operation of devices; accidents and the vigilance system; reprocessing of single-use devices; and concluding provisions — followed by five annexes, which are the notification form to the Zāļu valsts aģentūra, the electrical-safety and functional test record for active class IIa, IIb and III devices, the incident signal reports for health-care institutions and for natural persons, and the marking of the prohibition on re-use. Article 1 sets out the five matters the regulation governs, from essential requirements to distribution, operation, vigilance, post-market and technical supervision. The copy ingested is the consolidated gazette text, which carries the amendment annotations ("labojumu pamats") against the provisions they amend and shows the regulation as currently in force.

Ministru kabineta noteikumi Nr. 461 is the official identifier ZVA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.