Küsimused

Dear Sir/Madam,

The requirements for registration are set out in the Estonian Medical Devices Act, § 26, probably the following section is of the most interest but please do familiarize yourself with other national requirements:

(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 (OJ L 189, 20.07.1990, p 17–36) or Council Directive 93/42/EEC concerning medical devices (OJ L 169, 12.07.1993, p 1–43) 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 State Agency of Medicines thereof within 10 days after distribution of the relevant medical device for the first time.

This obligation is associated with an activity and not with a specific role of the actor. So if you are an importer who distributes devices in Estonia, then you have to fulfill the notification obligation in case of certain devices.

Also, it is not location specific nor does a registration in EUDAMED exclude an actor form fulfilling this national obligation.

Notification is done through a national database – EMDDB.

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 me know. In the case of the Estonian distributor, we kindly ask them to use secure authentication services to log into the database.

There are no fees associated with the fulfillment of the distributor notification or activities. If your application is correctly submitted, it will be approved within 14 days.

We recommend consulting the short user guide for using the EMDDB under “Forms” on the database homepage, as it contains more detailed information on which documents and information need to be provided with the notification.

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

Additionally, you can find some quidelines in English on our webpage.

Best regards,

Piret Põiklik
Head of Department

Department of Medical Devices
State Agency of Medicines

[email protected]
+372 5853 3610

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140

www.ravimiamet.ee

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Dear Sir/Madam

I am writing on behalf of Blackford Analysis based in Edinburgh in the UK.  Blackford Analysis has a Class I software medical device CE marked under MDR.  Blackford would like to better understand the registration requirements in Estonia.  I have reviewed the information on your website regarding registration requirements in Estonia and have a few questions which I would appreciate it if you could answer.  

• * Do manufacturers based outside of Estonia have an obligation to register in Estonia prior to selling product in Estonia or does this apply to manufacturers/EC Reps located in Estonia only?

• * If a manufacturer has registered in EUDAMED, is that sufficient or is registration in Estonia required too?

• * Given Blackford are in the UK and therefore outside of the EU, please confirm it would be our authorized rep that would complete the registration if it is required?

• * Do distributors need to register in Estonia?  Does this apply to both distributors based in Estonia and those not based in Estonia?

• * Do importers need to register in Estonia?  Does this apply to both importers based in Estonia and those not based in Estonia?

• * Is registration of the product required and who carries this out (distributor, manufacturer, EC Rep)? Can you advise if the process and requirements are the same for all classifications of product?

• * Can you please advise of the registration fees which apply in Estonia?

Thanks in advance for your help

Kind Regards

Lesley