Estonian Regulatory Authority
On 1 January 2010, three Estonian governmental health authorities (i.e. the Health Protection Inspectorate, the Health Care Board and the Chemicals Notification Centre) were united into one joint Health Board. The Health Board is a government agency within the Ministry of Social Affairs. Its main fields of activity are:
- medical devices;
- communicable diseases and control;
- environmental health;
- chemical safety.
|Estonian Health Board
Paldiski Maantee 81
Medical Devices Department
Põllu 1a e-mail: email@example.com
Ms Tagne Ratassepp – Head of Department
Questions concerning legislation, other general issues in relation to medical devices, Custom notifications
Phone: +372 580 943 39
Ms Kristina Kübar – Expert
Expertise of technical documentation and information exchange of non-compliant medical devices, Summary Evaluation Reports
Phone: +372 533 052 326
Mr Indrek Valvas – Expert
Phone: +372 580 936 17
The current Estonian Medical Devices Act entered into force on 1 December 2004 (last amendment entered into force on 1 March 2011). Several governmental regulations and regulations of the Minister of Social Affairs have also been published (in Estonian) to support the Act. These regulations stipulate and/or elaborate provisions of the Medical Devices Act and related European Directives, as follows:
- Regulation No 10: 2011 of the Minister of Social Affairs on notifications of placing of medical devices on the market and putting into service or starting distribution in Estonia market and notifications of sufficient changes on the devices;
- Regulation No 7: 2011 on notifications about the hazards and incidents occurred following placing of medical devices on the market and notification forms;
- Governmental Regulation No 343: 2004 on classification rules for medical devices;
- Governmental Regulation No 353: 2004 on Essential Requirements for the design, manufacturing and packaging of medical devices and accompanying information;
- Governmental Regulation No 354: 2004 on the regulations for the Conformity Assessment Procedures for medical devices;
- Regulation No 86: 2010 of the Minister of Social Affairs on the conditions and procedures for the clinical investigation of medical devices.
The Act and its associated regulations control the manufacturing, marketing, advertising and professional use of medical devices. They also specify rules for market supervision, and regulate the liability of interested parties for non-conformities, violations and perpetrations. The Act also contains references to other applicable regulations. As an example, the Product Conformity Act is referred to as the one regulating some responsibilities of manufacturers, distributors, certification and market supervisory authorities.
All the amendments to the European medical devise Directives, including 2007/47/EC, are transposed into Estonian legislation. At the moment amended version are available only in Estonian.
A medical device may only be placed on the market or put into use if the medical device:
- complies with the Medical Devices Act and other laws based upon it;
- has been clinically evaluated and, when necessary, undergone clinical trials;
- has been through conformity evaluation;
- is supplied with information for identifying the manufacturer and ensuring the safe and appropriate use of the product (such information must be on every medical device, package of every unit of the medical device, or both, or the marketing package of the medical device).
There is an obligation to involve Notified Body to perform procedure of overseeing the conformity of medical devise in class I sterile and/or with measuring function, class IIa, IIb and III or active implanted medical devices. At the present time there is no NB for medical devices in Estonia.
A medical device placed on the market or put into use in the European Union is allowed to be sold in Estonia, although there is a requirement for notification if the device is in Class IIa, IIb, III or AIMD (§ 26 of Medical Device Act); the notification of Class I devices and in vitro diagnostic medical devices is also recommended.
Notification consists of submission of at least the following information:
- the name and address of person responsible for placing a product on the Estonian market, responsible for distribution or put into service in Estonia;
- the name and address of manufacturer of medical devices and, if applicable the name and address of authorised representative in the EU;
- the name and intended purpose of the device in Estonian and English;
- the identification of the device (commercial name of the device, model or catalogue number).
With the completed notification form a distributor must provide:
- a copy of the user manual in Estonian;
- a copy of the original user manual;
- a copy of the labelling or packaging.
In addition, if the device is put into service, the application should include the following information:
- the name and address of health service provider;
- data identifying the medical device (additionally to mentioned above – serial / batch / LOT number).
If a manufacturer / Authorised Representative / importer located in Estonia releases a Class I product, custom-made medical device, a system or a procedure pack, or an in vitro diagnostic medical device to the European Union market, it has to be registered in the Estonian Health Board using the relevant notification form. Notifications should include the following documents and data:
- the full business name and address of the person responsible for placing a product on the EU market;
- the full business name and address of the manufacturer and, if applicable, the name and address of the authorized representative;
- data identifying the medical device (commercial name of the device, model or catalogue number);
- the name of the medical device in Estonian and English;
- class of the medical device;
- the intended purpose of the medical device as stated by the manufacturer in Estonian and English;
- Global Medical Device Nomenclature code.
With the completed registration form a distributor must provide:
- a copy of the Declaration of Conformity;
- a copy of the user manual in Estonian;
- a copy of the original user manual;
- a copy of the labeling or packaging;
- a statement concerning devices for special purposes in case of custom-made medical devices.
The Estonian Health Board will add the received information to the electronic database within 10 days of receiving a correctly completed notification form and then will issue an electronic (or on demand on the paper) confirmation letter.
There are no fees for registration or adding medical devices to the national medical devices database.
Labelling & language requirements
The information on the sales packaging (including the product name, if applicable) has to be in the Estonian language. It is also considered good practice to add the name and address of the distributor to the labelling, if the product has been manufactured outside Estonia.
The minimum packaging information is required to ensure the safe and appropriate use of the medical device must be in Estonian and must be displayed in an appropriate manner, taking into account the knowledge of the potential user. Other information concerning the medical device may be in any other European Member State language (English is most preferable), provided it is understandable by the user. The same principles apply to products meant only for the Estonian internal market.
Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly. Clinical investigation should follow standards adopted by Estonia EVS-EN ISO14155-1 & 2 (clinical investigations) and EVS-EN ISO 14971 (risk management).
When a medicinal product or a substance perceived as a medicinal product is involved in the investigation, the regulations on medicinal products apply in parts that concern the medicinal product/substance.
Clinical investigations shall be undertaken only when necessary information concerning the performance, safety and clinical benefit of the device cannot be obtained by other means than testing it on human beings. At the same time clinical investigations may be necessary irrespective of the risk classification of the device.
In case of uncertainty on the obligation to notify, please consult with Medical Devices Department.
The information provided in the notification form is used by the Health Board to assess if the notification is valid and to adjust the extent of the assessment procedure.
The manufacturer or his Authorised Representative must submit a written application to the Health Board to conduct a clinical investigation. A request should contain the following information:
- clinical Investigator´s Brochure, CIB;
- clinical Investigation Plan, CIP, with Case Report Form, CRF;
- statement that, except with regard to the aspects of the medical device covered by the investigation, the medical device meets the requirements specified in § 17 of the Medical Devices Act) ;
- a statement that, with regard to the aspects of the medical device covered by the investigation, every precaution has been taken to protect the health and safety of the patient;
- intended labelling of the device;
- copy of application to Ethics Committee (and its decision and statement if available when the notification is submitted – Health Board does not give approval until the Ethics Committee approval is obtained);
- information on the patient injury insurance policy covering participating subjects
- information to subjects (in Estonian);
- form for subject´s informed consent to participate (in Estonian);
- form for subject´s consent to disclosure of medical records (in Estonian);
- affidavit of clinical investigator´s qualifications.
And, if applicable:
- documentation of products/medicines/agents that the device under investigation will be used together/co-operate/be compared with;
- instructions for subjects or staff;
- evaluation forms to be filled in by subjects or staff.
Based on considerations related to human health and public order, the Health Board will either grant permission to conduct a clinical investigation of a medical device or refuse to grant such permission:
- within 60 days from the date of receipt of all required documentation in the case of an implantable medical device, Class III medical device, Class IIa device or Class IIb invasive medical device intended for long-time use;
- within 10 days from the date of receipt of all required documentation in the case of all other medical devices.
Ethics Committees in Estonia
1. Tallinn Medical Research Ethics Committee of the National Institute for Health Development
Tel +372 659 3924
Fax +372 659 3901
2. Ethics Review Committee on Human Research of the University of Tartu
(Office of Research and Development)
Ülikooli 18 - 304
Tel: +372 737 5514
Fax: +372 737 5508
Standards organisation in Estonia
Estonian Centre for Standardisation
Tel: +372 605 5050
Fax: +372 605 5070