Conformity assessment body (notified body) in Estonia

A company that wants to test, certify, inspect or calibrate products as a conformity assessment body for EU-harmonised product rules needs an activity licence from an EEA state and must be notified to the European Commission and the other EEA states²¹⁸. In Estonia the licence is granted under the Product Conformity Act by the Consumer Protection and Technical Regulatory Authority, or by the State Agency of Medicines for medical devices⁹. Accreditation for the same work is a precondition of the licence²⁴.

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

The Product Conformity Act (toote nõuetele vastavuse seadus, TNVS) defines conformity assessment as a procedure that shows whether a product, process, service, system, person or body meets specified requirements¹. A conformity assessment body is a body that carries out conformity assessment activities, including calibration, testing, certification or inspection².

A certificate of conformity is a document issued by the body confirming that a product or quality system meets the requirements named in it³. With the EU declaration of conformity the manufacturer confirms that the product meets the requirements of the relevant act; where an act requires the CE marking, the manufacturer or its authorised representative affixes it⁴.

The TNVS rules on conformity assessment bodies apply only where another act, a regulation issued under an act or an EU legal act requires them⁵, and the chapter on conformity assessment applies only in the harmonised field, i.e. where the product requirements come from EU harmonisation legislation based on Decision No 768/2008/EC⁶.

The legal act and the authority

Legal act: the Product Conformity Act, wording in force from 1 July 2025⁷. The General Part of the Economic Activities Code Act (majandustegevuse seadustiku üldosa seadus, MSÜS) applies with the exceptions set in the TNVS⁸.
Authority: the Consumer Protection and Technical Regulatory Authority (Tarbijakaitse ja Tehnilise Järelevalve Amet, TTJA) grants the licence; in the field of medical devices the State Agency of Medicines (Ravimiamet) grants it⁹. The authority supervising the market in the relevant field may be involved in granting the licence¹⁰.
Notification: the authority that granted the licence notifies the European Commission and the other Member States; during notification the body receives an identification number¹¹. Such a body is called a notified body (teavitatud asutus)¹².
Register: the grant, suspension or revocation of the licence is published as an entry in the Register of Economic Activities (majandustegevuse register, MTR)¹³, which is kept by TTJA¹⁴.
Accreditation: accreditation is organised under Chapter II of Regulation (EC) No 765/2008¹⁵. The Estonian national accreditation body is a non-profit legal person founded by the state and designated by a Government order¹⁶; it publishes the names and scope of accredited bodies on its website¹⁷.

Who must apply

To act as a conformity assessment body, a person must hold an activity licence granted by an EEA contracting state and must have been notified to the European Commission and the other EEA states¹⁸. The act names these cases outside the general licence route:

a body named in a mutual recognition agreement between the EU and a third country may also act as a conformity assessment body¹⁹;
an in-house accredited body may be used where the applicable act allows it; it forms a separate part of an undertaking, serves only that undertaking and is not notified to other Member States or the Commission²⁰.

The rules applying to the EU and its Member States also apply to the EEA states, Switzerland and Turkey²¹.

Requirements for the applicant

The act sets these requirements for the body and for the applicant²²:

Seat and register: the person is entered in a register named in TNVS § 28(1).
Reputation: the reputation requirements of TNVS § 28(1) are met.
Separation: the conformity assessment activity is separated from the person's other activities.
Independence: the person acts independently.
Staff: the staff requirements of TNVS § 28(1) are met.
Means and competence: the necessary means to carry out the procedures and sufficient technical competence for the scope applied for.
Pay: the staff pay requirements of TNVS § 28(1) are met.
Insurance: liability insurance with a sum insured of at least 64,000 euros.
Sector rules: any further requirements of the EU harmonisation legislation of the field.

Compliance with the relevant harmonised standards creates a presumption of conformity with the requirements they cover²³. The applicant must be accredited for the conformity assessment applied for by an accreditation body under Regulation (EC) No 765/2008²⁴; if another EEA state's national accreditation body accredited it, the body files that body's surveillance report with the authority that granted its licence²⁵.

Once licensed, the body keeps conformity assessment records for at least ten years unless an act provides otherwise²⁶, keeps information confidential²⁷, and may use a subsidiary or subcontractor only with the client's consent, remaining fully responsible for its work²⁸. It informs the licensing authority of refused, restricted, suspended or withdrawn certificates and of any circumstance affecting the scope of its licence²⁹.

Whether anti-money laundering and counter-terrorist financing (AML/CFT) requirements or a minimum share capital apply is specified for the client's situation.

Documents filed with the application

General data (MSÜS)³¹: the company's name and registry code, contact details, the name of the field of activity with its classification code, the name and contact details of the signatory and the basis of their right of representation, and other data required by law. A company still being founded files its founding document instead of a registry code³².

Data required by the TNVS³³:

the products or product types for which the right to assess is sought, with references to the relevant acts;
the conformity assessment procedures the applicant wishes to perform, with references to the relevant acts;
the accreditation certificate or a copy of it;
a copy of the liability insurance policy.

Subcontractors: if the body uses a subcontractor, data on the subcontractor and its compliance, with a copy of the cooperation agreement³⁴.

Applications may be filed through the Estonian information gateway (Eesti teabevärav) or through a notary³⁵.

State fee and processing time

Whether a state fee applies to a TTJA conformity assessment body licence is specified for the client's situation. In the medical device field, among the fees for acts of the State Agency of Medicines, the State Fees Act (riigilõivuseadus, RLS) sets 2,590 euros for reviewing an application for designation of a conformity assessment body and 777 euros for notification of the designation and issue of the licence³⁶. Accreditation is paid separately to the national accreditation body: 300 euros for reviewing an accreditation application, plus a fee for the assessment itself that depends on time and complexity, and an annual fee³⁷.

The authority decides on the application within 30 days of its filing; the period runs from the filing of all required data. It may suspend the period for up to 30 days to remedy deficiencies and may extend it once by up to 30 days³⁸. The authority may ask for further information³⁹. These are the law's time limits, not a promise of a decision or a date.

Unless an act provides otherwise, the licence is granted for the period of validity of the accreditation certificate on which it is based, or for the period in which another objective and significant circumstance exists⁴⁰. The body may start work only after a two-week waiting period in which neither the Commission nor any Member State has raised objections to the notification⁴¹, and the register entry is made after that⁴².

What LexorCorp Global OÜ does and how to order

LexorCorp Global OÜ (registry code 12233761) prepares the activity licence application documentation: it sets out the requirements of the act for the activity from its official text, submits the application through the Register of Economic Activities and follows up the authority's questions in writing. The price is from €3,500, one-time; no VAT is added. State fees and accreditation fees are paid by the client and are not included.

LexorCorp does not give legal or tax advice, does not carry out accreditation or audits, and does not promise the licence, a date or any decision of TTJA, the State Agency of Medicines or the accreditation body.

Order: order form

Sources

TNVS § 4(1) p 12 — text in force from 01.07.2025
TNVS § 4(1) p 13 — text in force from 01.07.2025
TNVS § 21(1) — text in force from 01.07.2025
TNVS § 19(1), § 20(1) — text in force from 01.07.2025
TNVS § 2(1) — text in force from 01.07.2025
TNVS § 2(3) — text in force from 01.07.2025
Riigi Teataja header, TNVS (RT I, 11.03.2025, 3) — text in force from 01.07.2025
TNVS § 2(8) — text in force from 01.07.2025
TNVS § 30(1¹) — text in force from 01.07.2025
TNVS § 30(1²) — text in force from 01.07.2025
TNVS § 34(1) — text in force from 01.07.2025
RLS § 285⁵ heading; TNVS § 27(1) — text in force from 01.11.2026
TNVS § 35(1) — text in force from 01.07.2025
MSÜS § 8(4) — text in force from 01.09.2025
TNVS § 36 — text in force from 01.07.2025
TNVS § 37(1)-(2) — text in force from 01.07.2025
TNVS § 38(1) p 6 — text in force from 01.07.2025
TNVS § 27(1) — text in force from 01.07.2025
TNVS § 27(2) — text in force from 01.07.2025
TNVS § 26(1)-(3) — text in force from 01.07.2025
TNVS § 2(7) — text in force from 01.07.2025
TNVS § 28(1) p 1-11 — text in force from 01.07.2025
TNVS § 28(2) — text in force from 01.07.2025
TNVS § 28(3) — text in force from 01.07.2025
TNVS § 28(4) — text in force from 01.07.2025
TNVS § 23(5) — text in force from 01.07.2025
TNVS § 24(1) — text in force from 01.07.2025
TNVS § 25(1)-(2) — text in force from 01.07.2025
TNVS § 23(1) p 1-2 — text in force from 01.07.2025
MSÜS § 19(2) p 1, § 15(1) p 1-4, 7 — text in force from 01.09.2025
MSÜS § 19(4) — text in force from 01.09.2025
TNVS § 29(1) — text in force from 01.07.2025
TNVS § 29(2) — text in force from 01.07.2025
MSÜS § 9(1) — text in force from 01.09.2025
RLS ch 8 div 6 (TTJA acts, no TNVS item); RLS § 285⁵(1)-(2) in ch 12 div 1 (Ravimiamet) — text in force from 01.11.2026
TNVS § 38¹(1)-(2), § 38²(1) p 1, § 38³(1), § 38⁴(1) — text in force from 01.07.2025
MSÜS § 20(1)-(3) — text in force from 01.09.2025
MSÜS § 19(6) — text in force from 01.09.2025
TNVS § 30(2) — text in force from 01.07.2025
TNVS § 34(2) — text in force from 01.07.2025
TNVS § 35(3) — text in force from 01.07.2025

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

Sources in the text are named without links; the official texts are linked under Official sources. To see which of our services your company needs, open the Business Navigator.