An activity licence of a conformity assessment body must be applied for if you want to start product conformity assessment. The licence is issued by the Consumer Protection and Technical Regulatory Authority. For medical devices, the licence is issued by the Health Board.
Legal bases
The activities of conformity assessment bodies shall be governed by the following legislation:
- Product Conformity Act
- Equipment Safety Act
- General Part of the Economic Activities Code Act
- Requirements for building materials and construction products and procedure for attestation of conformity
Additional requirements for conformity assessment and for products, processes, or persons are derived from directives or standards applicable to specific products.
Requirements for an applicant
To be issued an activity licence, you must meet the following requirements as a conformity assessment body:
- the person is entered in the commercial register and the register of non-profit associations and foundations;
- the person, including their shareholders and members holding more than 50 per cent of the shares, and their employees, who have significant decision-making powers by virtue of their occupation, have an impeccable reputation;
- the person’s activities as a conformity assessment body are distinguished from its other activities in organisational and accounting terms;
- the person is able to act independently, professionally, impartially, and in a non-discriminatory manner;
- the person has sufficient staff with the education, training, and experience required to carry out the conformity assessment referred to in the application who are familiar with the requirements of EU harmonisation legislation and of harmonised standards applicable to the products indicated in the application for the activity licence and to the extent of the activity licence issued;
- the person has the necessary means to perform conformity assessment procedures;
- the person is technically competent to carry out the conformity assessment procedures specified in the application for the activity licence and to the extent of the activity licence issued;
- the person or any person employed may not be the designer, manufacturer, authorised representative of the manufacturer, importer or distributor, supplier, installer, maintainer, owner, or user of the products subject to the conformity assessment, or the representative of these persons. Likewise, their other activities shall not relate to the products concerned to the extent that their independence or impartiality is doubted, including the provision of consultancy services by such person or by a conformity assessment employee. Nothing in this clause shall prejudice the right of a conformity assessment person to use a product under conformity assessment for a conformity assessment procedure or for personal use;
- the personnel of the conformity assessment body shall be remunerated regardless of the number and results of the conformity assessment procedures;
- the person shall have, at the time of their activity as a conformity assessment body, valid liability insurance in a sum which guarantees, in its activities as a conformity assessment body, compensation for third party damage and which is at least EUR 64,000;
- the person meets the other requirements of the EU harmonisation legislation applicable to their area of activity.
If a person demonstrates compliance with the criteria laid down in the relevant harmonised standards or parts thereof, they shall be presumed to satisfy the requirements of the legislative instrument that are covered by those standards.
The conformity assessment body and the applicant for an activity licence of a conformity assessment body must be accredited by an accreditation body under Regulation (EC) No 765/2008 for the purpose of the conformity assessment.
Cross-border operation
The activity licence of a conformity assessment body is issued on a site-by-site basis, but also allows services to be provided from abroad if subject to the appropriate accreditation.
Filling out and submitting the application
The following information and supporting documents must be submitted together with the free-form application for the activity licence:
- data provided by the General Part of the Economic Activities Code Act;
- the products or types of products for which the applicant wishes to be granted the activity licence for the conformity assessment and references to relevant legislation;
- the conformity assessment procedures that the applicant wishes to carry out as a conformity assessment body, and references to relevant legislation;
- an accreditation certificate or a copy thereof;
- a copy of the liability insurance policy;
- details of the subcontractor and their compliance.
The application can be submitted:
- By entering the Register of Economic Activities (use of the service requires logging in with an EU eID, ID-card, Mobile-ID, Smart-ID or via Internet bank);
- By sending the digitally signed application form to the e-mail address: [email protected];
- By sending the application to the Consumer Protection and Technical Regulatory Authority via mail: Endla 10a, 10142 Tallinn.
Payment of the state fee
A state fee of 20 euros must be paid to the bank account of the Ministry of Finance with reference number 2900082430:
- SEB - EE891010220034796011 (BIC/SWIFT: EEUHEE2X)
- Swedbank - EE932200221023778606 (BIC/SWIFT: HABAEE2X)
- LHV - EE777700771003813400 (BIC/SWIFT: LHVBEE22)
- Luminor - EE701700017001577198 (BIC/SWIFT: RIKOEE22)
Processing an application
The application will be processed within 30 days. You will be notified by e-mail or regular mail of the issue of the activity licence. The activity licence is issued electronically.
If the application is incomplete, you will be contacted within 30 days of the submission of the application. You will be given the opportunity to remedy the deficiencies within a specified period. Once the deficiencies have been rectified, the licence shall be issued within 30 days.
An application for the renewal of an activity licence shall be made to the Consumer Protection and Technical Regulatory Authority by e-mail or regular mail at least 30 days before the expiry date of the activity licence.
Changing the conditions of an activity licence
If you wish to change the scope or extend the validity of an existing activity licence, the application must include data and documents that you have not previously submitted or that have changed in a section covered by the previously submitted document.
Termination of an activity licence and economic activities
If you wish to terminate your activity in the chosen field, please submit a digitally signed application to the Consumer Protection and Technical Regulatory Authority at [email protected].
Declaring an activity licence invalid
The activity licence shall be declared invalid at the request of the applicant or if the activities of the company do not meet the requirements of a conformity assessment body.
The issuer of the activity licence may also declare the activity licence invalid if:
- the conformity assessment body does not allow for state oversight of its activities;
- the conformity assessment body has significantly or repeatedly infringed the requirements of its activities;
- the conformity assessment body continues to perform its activities as a conformity assessment body while the validity of its activity licence is suspended.
In the event of the declaration of an activity licence of a conformity assessment body invalid, the conformity assessment body shall submit its documentation on conformity assessment to the Consumer Protection and Technical Regulatory Authority. The documentation need not be delivered if the conformity assessment body’s activity licence is declared invalid partially.
Supervision
The activities of the conformity assessment body shall be subject to state supervision by the Consumer Protection and Technical Regulatory Authority.
The activities of a conformity assessment body of medical devices shall be subject to state supervision by the Health Board.
Contact details
Substantive information
Priit Poschlin
Consumer Protection and Technical Regulatory Authority, phone: 667 2193, e-mail: [email protected]
Registry information and technical questions
Register of Economic Activities, phone: +372 668 7080, e-mail: [email protected]