Vastuskiri

Dear Kristupas Žegunis,

Thank you for your enquiry.

There is a distribution notification obligation in Estonia and it is based on Medical Device Act § 26 (4):

Every undertaking who distributes on the market of Estonia a system or procedure pack of medical devices according to Article 22 of Regulation (EU) 2017/745 of the European Parliament and of the Council or a class IIa, IIb or III medical device classified according to Regulation (EU) 2017/745 of the European Parliament and of the Council or Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices or Council Directive 93/42/EEC concerning medical devices or class B, C or D in vitro diagnostic medical devices classified according to Annex VIII of Regulation (EU) 2017/746 of the European Parliament and of the Council, shall notify the Health Board thereof within 10 days after distribution of the relevant medical device for the first time.

Notification about distribution can be completed through our national Medical Devices and Appliances Database, https://msa.sm.ee/eng. Under forms you can find short guide for using the Estonian Medical Device Database. There you can find also documents required with the application for Class IIa, IIb and III medical devices:

· EC certificate(s)

· Declaration of conformity

· Instructions for use in English

· Instructions for use in Estonian

· A copy of the packaging / labelling of the device as a surface layout (for lay-users one-to-one translation from the original packaging)

For actors outside of Estonia we can make an account manually, so it is possible to log into the database with username and password. For creating an account we need a contact person’s full name and e-mail.  If there is a need for an account, please let us know.

Please do not hesitate to contact me for further information or with any questions.

Best regards,

Egle Audova

Chief Specialist

Department of Medical Devices

Phone +372 5566 7596

[email protected] | [email protected]  

This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.

Good day,

I represent company Biomedika which is located in Lithuania, Vilnius. We are the distributor of several companies – manufacturers of medical devices, mostly implants for various orthopaedic surgeries. We operate in Baltic countries including Estonia. Wanted to know what is the process of registering the medical devices in Estonia? We are very well familiar with the processes in Lithuania and Latvia and would appreciate if you could navigate us with the registration procedure in your country.

Best regards,

Dear Kristupas Žegunis,

Thank you for your enquiry.

There is a distribution notification obligation in Estonia and it is based on Medical Device Act § 26 (4):

Every undertaking who distributes on the market of Estonia a system or procedure pack of medical devices according to Article 22 of Regulation (EU) 2017/745 of the European Parliament and of the Council or a class IIa, IIb or III medical device classified according to Regulation (EU) 2017/745 of the European Parliament and of the Council or Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices or Council Directive 93/42/EEC concerning medical devices or class B, C or D in vitro diagnostic medical devices classified according to Annex VIII of Regulation (EU) 2017/746 of the European Parliament and of the Council, shall notify the Health Board thereof within 10 days after distribution of the relevant medical device for the first time.

Notification about distribution can be completed through our national Medical Devices and Appliances Database, https://msa.sm.ee/eng. Under forms you can find short guide for using the Estonian Medical Device Database. There you can find also documents required with the application for Class IIa, IIb and III medical devices:

· EC certificate(s)

· Declaration of conformity

· Instructions for use in English

· Instructions for use in Estonian

· A copy of the packaging / labelling of the device as a surface layout (for lay-users one-to-one translation from the original packaging)

For actors outside of Estonia we can make an account manually, so it is possible to log into the database with username and password. For creating an account we need a contact person’s full name and e-mail.  If there is a need for an account, please let us know.

Please do not hesitate to contact me for further information or with any questions.

Best regards,

Egle Audova

Chief Specialist

Department of Medical Devices

Phone +372 5566 7596

[email protected] | [email protected]  

This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.

Good day,

I represent company Biomedika which is located in Lithuania, Vilnius. We are the distributor of several companies – manufacturers of medical devices, mostly implants for various orthopaedic surgeries. We operate in Baltic countries including Estonia. Wanted to know what is the process of registering the medical devices in Estonia? We are very well familiar with the processes in Lithuania and Latvia and would appreciate if you could navigate us with the registration procedure in your country.

Best regards,