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Reportincidents  with medical devices


A “Vigilance incident report”  must be submitted to the State Agency of Medicines (SAM) within three days after any incident or potentialincident related to the use of a medical device that has resulted in or may result in death or serious harm to the health of a patient, user or third person, and the manufacturer or authorised representative of the manufacturer, or distributor of the medical device must be informed. Please report electronically to the following SAM e-mail address: or paper format documentation may be submitted to SAM in person (Room 11) or sent via mail to SAM address: Jersikas iela 15, Riga, LV‑1003, the Agency can also be contacted by phones: (+371) 67078424, (+371) 29447659 or fax: (+371) 67078428.

Regulation No. 461 of the Cabinet of Ministers of the Republic of Latvia Medical Devices Regulation, adopted on August 15, 2023, Appendix 3

Regulations No. 582 Regulations for in vitro diagnostic medical devices, adopted on October 10, 2023, Appendix 2