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:
Estonian Health Board
Paldiski mnt 81
Medical Devices Department
phone: +372 744 7409
Dr Andrei Knuut – Head of Department
Mrs Tagne Ratassepp – Expert
Questions concerning legislation, classification of medical devices, clinical investigations of medical devices, Summary Evaluation Reports (SER) and other questions concerned market surveillance
Mrs Sofia Hratkevich – Expert
Questions concerning medical devices registration/notification and vigilance information exchange
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:
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:
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:
With the completed notification form a distributor must provide:
In addition, if the device is put into service, the application should include the following information:
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:
With the completed registration form a distributor must provide:
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.
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:
And, if applicable:
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:
Ethics Committees in Estonia
Tallinn Medical Research Ethics Committee of the National Institute for Health Development
Tel. +372 659 3924
Fax +372 659 3901
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
Estonian Centre for Standardisation
Tel. +372 605 5050
Fax +372 605 5070