Placing medical devices on the market in Estonia

A company that manufactures, imports or distributes medical devices in Estonia must meet the obligations of the EU Medical Devices Regulation and the Estonian Medical Devices Act⁵. Manufacturers, authorised representatives and importers register in the EU database EUDAMED¹¹, and distributors notify the State Agency of Medicines (Ravimiamet) of devices of the higher risk classes¹³. This page sets out those obligations as the acts state them.

Information as of 11 November 2026. Every numbered statement of this page was checked in the official text named below and re-checked by a second reviewer on 2026-11-11. The page is general information, not legal advice; the authority decides on every application.

What the activity is

A medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article that the manufacturer intends for a medical purpose and that does not achieve its principal intended action by pharmacological, immunological or metabolic means¹.

Regulation (EU) 2017/745 on medical devices (MDR) does not cover in vitro diagnostic devices (which fall under Regulation (EU) 2017/746), medicinal products or cosmetic products².

The MDR defines these economic operators; the term also covers a person who puts together systems or procedure packs³:

Manufacturer — as defined in MDR Art 2(30).
Authorised representative — as defined in MDR Art 2(32).
Importer — a person established in the EU who places a device from a third country on the EU market.
Distributor — any other person in the supply chain who makes a device available on the market, up to putting it into service.

"Placing on the market" is the first making available of a device on the EU market⁴.

The legal act and the authority

The activity is governed by Regulation (EU) 2017/745 and, in Estonia, by the Medical Devices Act (meditsiiniseadme seadus, MSS). The MSS applies the general Product Conformity Act to the obligations of manufacturers, authorised representatives, importers and distributors, with the exceptions the MSS and the MDR set⁵.

The competent authority under the MSS and the MDR is the State Agency of Medicines (Ravimiamet)⁶. Ravimiamet also carries out state supervision of these requirements⁷.

There are two registers:

EUDAMED, the European database on medical devices. Manufacturers, authorised representatives and importers register there and receive a single registration number (SRN)⁸. The European Commission declared the first four EUDAMED modules functional by Decision (EU) 2025/2371, and their use has been mandatory since 28 May 2026⁹.
The Estonian medical devices and assistive devices database (MSA), a state database for which Ravimiamet is the controller. Manufacturers, authorised representatives, importers and distributors submit data to it¹⁰.

Who must register or notify

Manufacturers, authorised representatives and importers must register in EUDAMED before placing a device (other than a custom-made device) on the market. Where a notified body takes part in the conformity assessment, they must register before applying to it¹¹.
A manufacturer outside the EU may place a device on the EU market only if it designates a sole authorised representative¹².
A distributor of class IIa, IIb or III devices, active implantable devices, systems or procedure packs, or of class B, C or D in vitro diagnostic devices must notify Ravimiamet within ten days of first distributing the device in Estonia¹³. Whether a notice is needed for class I devices and class A in vitro diagnostic devices is specified for the client's situation.
A company making a custom-made device available must notify Ravimiamet at least ten days before doing so¹⁵.

A distributor or importer that markets a device under its own name or trade mark takes on the obligations of a manufacturer¹⁶.

Requirements for the economic operator

Manufacturer. It must have a risk management system, a clinical evaluation, technical documentation, a quality management system and a post-market surveillance system; for a device other than a custom-made one, it must draw up an EU declaration of conformity and affix the CE marking¹⁷. Before placing a device on the market, it carries out the conformity assessment for the device's risk class; class I devices are self-declared, but if they are sterile, have a measuring function or are reusable surgical instruments, a notified body assesses those aspects; classes IIa, IIb and III involve a notified body¹⁸. It must have measures that give sufficient financial coverage for its potential liability for defective products¹⁹.

Person responsible for regulatory compliance (PRRC). A manufacturer must have within its organisation at least one PRRC meeting the qualification requirements of MDR Art 15(1). Micro and small enterprises need not employ the PRRC but must have one permanently and continuously at their disposal. An authorised representative must have a PRRC permanently and continuously at its disposal²⁰.

Authorised representative. Its written mandate must cover at least the tasks the MDR lists, including verifying the declaration of conformity and the technical documentation and meeting the registration obligations²¹.

Importer and distributor. Before supplying a device, they must verify that it bears the CE marking, has a declaration of conformity and is labelled correctly. They must also keep a register of complaints, non-conforming devices, recalls and withdrawals²².

Language and records. Information supplied with a device made available in Estonia must be in Estonian if the device is meant for lay users. For devices meant only for professional users, Estonian or English is allowed. The declaration of conformity must be in Estonian or English²³. The manufacturer or its authorised representative keeps the device documents available to Ravimiamet for at least ten or 15 years²⁴.

Capital and AML/CFT. Whether a minimum share capital or anti-money laundering rules apply is specified for the client's situation.

Information and documents submitted

EUDAMED actor registration²⁵:

type of operator (manufacturer, authorised representative or importer);
name, address and contact details of the operator;
name, address and contact details of the PRRC.

EUDAMED device registration by the manufacturer²⁶: the Basic UDI-DI (the device's unique identifier), the notified body certificate where there is one, the risk class, the Member States where the device is made available (for class IIa, IIb and III), and the other data that Annex VI to the MDR lists.

Notification to Ravimiamet through MSA: according to Ravimiamet, the database holds general information, the instructions for use and a copy of the packaging for each notified device²⁷.

State fee and time limits

Whether a state fee applies to EUDAMED registration or a distribution notice under the MSS is specified for the client's situation. The State Fees Act (riigilõivuseadus) sets fees for related acts. A free sales certificate costs €154 when it is issued within 45 days, or €308 when it is issued within five working days at the applicant's request. Reviewing a clinical investigation application costs €210²⁸.

The time limits in the acts bind the operator:

ten days for distribution and custom-made device notices¹³¹⁵;
one week to update registration data after a change;
confirming the data one year after registration and every second year after that²⁹.

Any time limit mentioned here is the law's, not a promise of when the authority will act.

MSS § 39 provides for a fine of up to 200 fine units. For a legal person, the fine is up to €32,000³⁰.

What LexorCorp Global OÜ does and how to order

For this activity, LexorCorp Global OÜ offers Activity licence application documentation, priced from €3,500; no VAT is added. The service covers:

the requirements of the act for the activity, from its official text;
preparing the registration and notification documents;
managing the process, including written follow-up of the authority's questions.

The client provides the device data, the technical documentation and the PRRC. LexorCorp Global OÜ does not act as the authorised representative or the PRRC. It also does not carry out conformity assessment or clinical evaluation. The price does not include notified body fees, legal advice, audit or tax advice. This is document preparation, not legal advice. Ravimiamet and the notified body decide, and no outcome or date can be promised.

Order: Activity licence application documentation

Sources

MDR Art 2(1) — text in force from consolidated version 2026-11-09
MDR Art 1(6)(a),(b),(e) — text in force from consolidated version 2026-11-09
MDR Art 2(30),(32),(33),(34),(35) — text in force from consolidated version 2026-11-09
MDR Art 2(28) — text in force from consolidated version 2026-11-09
MSS § 2(1) — text in force from 2026-10-01 (RT I, 30.06.2026, 96)
MSS § 14^1(1) — text in force from 2026-10-01 (RT I, 30.06.2026, 96)
MSS § 33(1) — text in force from 2026-10-01 (RT I, 30.06.2026, 96)
MDR Art 31(2) — text in force from consolidated version 2026-11-09
European Commission EUDAMED overview; MDR Art 123(3)(d) — text in force from page as read 2026-11-11
MSS § 29(1),(2),(5) — text in force from 2026-10-01 (RT I, 30.06.2026, 96)
MDR Art 31(1) — text in force from consolidated version 2026-11-09
MDR Art 11(1) — text in force from consolidated version 2026-11-09
MSS § 26(4) — text in force from 2026-10-01 (RT I, 30.06.2026, 96)
MSS § 26(3) — text in force from 2026-10-01 (RT I, 30.06.2026, 96)
MDR Art 16(1)(a) — text in force from consolidated version 2026-11-09
MDR Art 10(2),(3),(4),(6),(9),(10) — text in force from consolidated version 2026-11-09
MDR Art 52(1),(3),(4),(6),(7) — text in force from consolidated version 2026-11-09
MDR Art 10(16) — text in force from consolidated version 2026-11-09
MDR Art 15(1),(2),(6) — text in force from consolidated version 2026-11-09
MDR Art 11(3) — text in force from consolidated version 2026-11-09
MDR Art 13(2),(6); Art 14(2),(5) — text in force from consolidated version 2026-11-09
MSS § 16(3),(5) — text in force from 2026-10-01 (RT I, 30.06.2026, 96)
MSS § 25(1) — text in force from 2026-10-01 (RT I, 30.06.2026, 96)
MDR Annex VI Part A Section 1 — text in force from consolidated version 2026-11-09
MDR Art 29(1),(4); Annex VI Part A Section 2 — text in force from consolidated version 2026-11-09
Ravimiamet, Meditsiiniseadmetest teavitamine — text in force from page as read 2026-11-11
RLS § 285^3(1), § 285^4(1),(3) (chapter 12, subchapter 1 'Ravimiameti toimingud', division 4 'Meditsiiniseadme seaduse alusel tehtavad toimingud') — text in force from 2026-11-01
MDR Art 31(4),(5) — text in force from consolidated version 2026-11-09
MSS § 39 — text in force from 2026-10-01 (RT I, 30.06.2026, 96)

Official sources

The laws this article names, each linked to its official text, as read on 9 October 2026. For the Estonian acts we read the English translation in Riigi Teataja; the legally binding text is the Estonian one.

State Fees Act — Riigi Teataja, English translation

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