Latvia medical device regulations

Ministru kabineta 2024. gada 18. decembra noteikumi Nr. 895, adopted 18 December 2024, in force since 1 January 2025, published in Latvijas Vēstnesis 249 of 20 December 2024, issued under Article 5(1) of the Public Agencies Law. The State Agency of Medicines’ paid-services price list, consisting of a single annex holding the tabulated price list, including the device-related entries that sit alongside the medicinal-product and pharmacy fees. This is the instrument Latvian applicants pay against, and it is the current price list — it replaced the earlier tariffs rather than amending them. Consolidated gazette text, currently in force.

Ministru kabineta 2023. gada 10. oktobra noteikumi Nr. 582, adopted 10 October 2023, in force since 13 October 2023, published in Latvijas Vēstnesis 198 of 12 October 2023. The IVD counterpart to Regulation No. 461 and issued under the same two authorising provisions — 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 eight chapters: general provisions; the notification procedure for in vitro diagnostic medical devices; the rights and duties of State administrative institutions; the procedure for entering information on IVD manufacturers, their devices and distributors into LATMED; authorisation to place an IVD on the market; distribution, use and operation; accidents and the vigilance system; and concluding provisions — with three annexes: the notification form to the Zāļu valsts aģentūra, the incident signal report for health-care institutions, and the report for a person who uses a device independently or on a health-care practitioner’s instruction. Consolidated gazette text, currently in force.

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.

Latvia is an EU member State, so Regulation (EU) 2017/745 applies directly and sits above Cabinet Regulation No. 461, which supplies the national notification, LATMED, authorisation and vigilance machinery the Regulation leaves to member States. The text is expressed once in eu.ts as eu-mdr-2017-745; this row is the Latvian metadata view onto it and opens the articles the national layer hangs off: manufacturer obligations (Art. 10), importer and distributor obligations (Arts. 13 and 14), EUDAMED registration (Arts. 30 and 31) and vigilance (Art. 87). It is not a second corpus copy.

Ministru kabineta 2012. gada 31. jūlija noteikumi Nr. 537, adopted 31 July 2012, in force since 1 January 2013, published in Latvijas Vēstnesis 123 of 7 August 2012, issued under Article 4(2) of the Public Agencies Law. The statute that constitutes the Zāļu valsts aģentūra (State Agency of Medicines), the authority the jurisdiction registry records as Latvia’s regulator and the body the device regulations name for notification, LATMED and vigilance. In four chapters: general provisions, the agency’s functions, tasks and rights, the agency’s governance and the arrangements securing the lawfulness of its activity, and concluding provisions. Thirteen articles. Consolidated gazette text, currently in force.

Ārstniecības likums, adopted by the Saeima on 12 June 1997, promulgated by the President, in force since 1 October 1997, published in Latvijas Vēstnesis 167/168 of 1 July 1997 and in Saeimas un Ministru Kabineta Ziņotājs 15 of 7 August 1997. Consolidated text as currently in force, in sixteen chapters: general provisions; health-care supervision; medical ethics committees; rights and duties of persons in health care; health-care practitioners and their activity; the medical profession; the dental profession; the nursing and physician-assistant professions; the functional specialist; the midwife, military paramedic and masseur professions; the duties and rights of practitioners in treatment; the pharmacist’s activity in health care; health-care institutions; alcohol, narcotic, psychotropic and toxic substances and gambling in health-care institutions; mental illness; health and working capacity, forensic-medical and forensic-psychiatric examination; termination of the activity of a health-care institution; the health information system; special provisions on the economic activity of health-care institutions; and administrative offences in the provision of health-care services, plus transitional provisions. Article 34(2) is the provision under which the Cabinet issues the medical device and IVD regulations, so this law is the statutory basis Latvian device rules are read against.

Union instrument, expressed once in eu.ts as eu-regulation-2023-607. This Latvian row is a metadata view onto that expression. It matters to Latvia because the transitional periods it set for devices covered by a valid Directive 90/385/EEC or 93/42/EEC certificate (Article 120(3a) to (3f) MDR), and the corresponding IVDR period in Article 110(4), determine how long those certificates remain a route into the Latvian market. It is not a second corpus copy.