Estonia medical device regulatory resources

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 Estonian notification and database duties, none of which has a guaranteed processing time

This is a national reporting clock, not a review clock: 'Iga ettevõtja, kes levitab Eesti turul ... IIa, IIb või III riskiklassi meditsiiniseadet või ... B-, C- või D-klassi in vitro diagnostikameditsiiniseadet, teavitab sellest Ravimiametit kümne päeva jooksul asjaomase meditsiiniseadme esmakordsest levitamisest arvates'

The same ten-day period applies to a system or procedure pack within the meaning of MDR Article 22 and to an active implantable device, so one clock spans several risk classes rather than belonging to any single one

It binds the undertaking that distributes the device, which may be an importer or distributor rather than the manufacturer, and the notification does not gate the distribution

A separate ten-day period runs in advance of placing a custom-made device on the market (MSS § 26(3)), and a ten-working-day period applies to submitting the list of in-house manufactured devices (MSS § 26(1))

Verbatim: 'Ravimiamet registreerib talle teatatud ohujuhtumi andmed ja teavitab sellest andmete esitajat kümne tööpäeva jooksul andmete esitamisest arvates'

This is the national acknowledgement of an incident report, not a market-entry clock, and it applies to every device class alike

A field safety notice for a device made available on the Estonian market must be drawn up in Estonian; the initial urgent notice may be in English (MSS § 27(2))

This is the national competent-authority clock, not a conformity-assessment clock: State Fees Act § 28⁵⁴(1) charges EUR 154 for a certificate issued within 45 days of the application, and § 28⁵⁴(3) charges EUR 308 for one issued within five working days at the applicant's request

The published clock is a service period attached to the state fee rather than a decision deadline on a market-entry application, and it applies to every device class alike

A certificate is issued only once the devices are registered in the medical devices and aids database and the data are current, so the period is not a substitute for the registration duty

Ravimiamet's own service page still cites the repealed § 29⁸² of the State Fees Act as the legal basis for the fee; the provision now in force is § 28⁵⁴