Latvia medical device registration timeline

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is EUDAMED actor and device registration plus the Latvian duties: a class I manufacturer whose place of business is registered in Latvia applies to the agency under § 28 of Cabinet Regulation No. 461 and the agency enters the information in the LATMED database within ten days under § 31

Verbatim § 11: '10 darbdienu laikā pēc šo noteikumu 9. punktā minētās informācijas saņemšanas aģentūra savā tīmekļvietnē nodrošina publisku pieejamību vismaz paziņošanas procedūras ietvaros saņemtajiem datiem par medicīnisko ierīci, tās ražotāju, pilnvaroto pārstāvi (ja attiecināms) vai paziņotāju un aģentūras piešķirto paziņojuma numuru. Pēc šīs informācijas publiskošanas aģentūras tīmekļvietnē paziņošanas procedūra uzskatāma par pabeigtu.'

The duty in § 9 falls on persons who begin to place IIa, IIb and III class devices on the Latvian market and requires the completed notification form (Annex 1) together with a copy of the EU declaration of conformity and copies of the valid notified-body certificates, so one clock spans three classes rather than belonging to any single one

The clock stops at publication, not at an approval decision, and the notification does not gate the placing of the device on the market

Verbatim § 31: 'Aģentūra izskata šo noteikumu 28. un 29. punktā minētos iesniegumus un 10 dienu laikā pēc to saņemšanas ievada attiecīgo informāciju LATMED datubāzē.'

The clock is route-wide and not class-specific: § 28 covers the manufacturers of class I devices and the assemblers of systems and procedure packs, and § 29 covers distributors, whichever class they handle

The registration is a precondition of distribution rather than of the CE route: § 41.1 provides that distributors may make devices available on the Latvian market only if the information about them as a distributor has been entered in the LATMED database, and § 41.2 extends that to manufacturers, importers and authorised representatives from 1 January 2026

The same section fixes a ten-working-day change-report clock (§ 32) and a ten-working-day discontinuation report with a seven-day agency entry (§ 34), which are not separately published here

Verbatim from ZVA's page: 'Brīvās tirdzniecības sertifikātu ZVA izsniedz 30 dienu laikā pēc iesnieguma un tam pievienoto dokumentu saņemšanas.' The agency issues the certificate in Latvian and English on the application of a manufacturer of a medical device or an in vitro diagnostic medical device, for devices manufactured in Latvia that are marked with the CE marking

The period is route-wide and class-independent, and it is published by the agency rather than in the regulation: § 23 of Cabinet Regulation No. 461 provides for the certificate and the costs but fixes no period

This is an export and free-sale certificate, not a route onto the Latvian market; the service is chargeable at EUR 185.41 under item 54 of the agency fee schedule

Verbatim § 70: 'Ārstniecības iestādes pārstāvis triju dienu laikā pēc nopietna negadījuma vai varbūtēja nopietna negadījuma ar medicīnisko ierīci nosūta aģentūrai medicīniskās ierīces lietotāja negadījuma ziņojumu (turpmāk – signālziņojums) ... un informē ražotāju vai pilnvaroto pārstāvi, vai izplatītāju'

Verbatim § 74.1: the person who uses the device, or their representative, 'triju dienu laikā informē par to aģentūru, iesniedzot signālziņojumu'

This is a national reporting clock, not a market-entry clock, and it applies to every device class alike