Vastus päringule

Dear Irena,

I will answer your questions within your letters by using the color blue, please see below.

When you have additional questions regarding EUDAMED you can contact the EUDAMED support directly by email: [email protected]

Best regards,

Egle Audova

State Agency of Medicines

Specialist

Department of Medical Devices

[email protected]

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

www.ravimiamet.ee

Selles e-kirjas sisalduv teave (kaasa arvatud manused) on mõeldud ametialaseks kasutamiseks ning seda võivad kasutada vaid e-kirja adressaadid. E-kirjas sisalduvat teavet ei tohi ilma saatja selgelt väljendatud loata edasi saata ega mis tahes viisil kolmandatele isikutele avaldada. Juhul, kui Te olete saanud käesoleva e-kirja eksituse tõttu, teavitage sellest koheselt saatjat ning kustutage e-kiri.
This e-mail and any attachments transmitted may contain confidential and privileged information.  If you are not the intended recipient, please notify the sender immediately by returning the e-mail and permanently deleting what you have recieved. Any dissemination or use of this information by a third person without permission is prohibited and may be illegal.

·         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.

Dear Irena Milobratovic,

Thank you for your inquiry.

There is a placing on the market and distribution notification obligation for medical devices in Estonia and it is based on Medical Device Act  Act § 41² and §26 (4) (currently available only in Estonian):

Relevant for you is Medical Device Act § 41² that regulates the period when EUDAMED is not functional as required by the MDR article 34. The wording of the Medical Device Act § 41² is as follows (please be aware that this is not an official translation) :

Implementation of obligations and requirements related with European database on medical devices

Until the European medical device database, as provided in Article 123(3) of Regulation (EU) 2017/745 and Article 113(3) of Regulation (EU) 2017/746, is implemented, communication shall take place in accordance with the version of this Act in force as of December 31, 2022, and the regulations established thereunder, considering that the competent authority is the State Agency of Medicines.

The wording of the act can be found here, and the relevant paragraph is § 26 (1):

Any person who places a class I medical device, custom-made medical device, system of medical devices, procedure pack or in vitro diagnostic medical device on the market in Estonia, shall notify, at least ten days before the medical device is placed on the market, the Health Board of the intention to place the medical device on the market and of any significant alterations of the medical device.

As the competence is transferred from the Health Board to the State Agency of Medicines starting on 01.01.2025, therefore the different name in the previous version of Medical Device Act.

The obligation to place the device on the Estonian market can be fulfilled through the Estonian Medical Device Database (EMDDB, https://msa.sm.ee/).

Also, please use a short guide for using the Estonian Medical Device Database that can be found on database homepage under „Forms“. It is a step-by-step guide on how to carry out the notification process successfully in the database.

The required documents for device notification include: declaration of conformity, instructions for use, and a copy of the labeling or packaging.

As there is a  gradual roll-out of EUDAMED, it may change the process. At this moment the national legislation has not changed, the process of placing a class I medical device on the market in Estonia remains as written.

You can find relevant guidelines regarding EUDAMED can be found here.

There is  also a distribution notification obligation for medical devices in Estonia and it is based on § 26 (4) (currently available only in Estonian):

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 State Agency of Medicine thereof within 10 days after distribution of the relevant medical device for the first time.

The obligation to notify about the mentioned distribution can also be fulfilled through EMDDB.

As mentioned above, notification is mandatory for higher-risk class devices. There is no obligation to notify for class I medical device, but you may do so voluntarily. 

Additionally, please familiarize yourself with the language requirements, can be found in Medical Device Act, § 16 (3) (currently available only in Estonian), but you can see previous wording. Briefly, if the device is intended for lay users, all information must be provided in Estonian. If the device is intended for professional users, the information may be provided in Estonian or English.

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

Best regards,

Egle Audova

State Agency of Medicines

Specialist

Department of Medical Devices

[email protected]

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

www.ravimiamet.ee

Selles e-kirjas sisalduv teave (kaasa arvatud manused) on mõeldud ametialaseks kasutamiseks ning seda võivad kasutada vaid e-kirja adressaadid. E-kirjas sisalduvat teavet ei tohi ilma saatja selgelt väljendatud loata edasi saata ega mis tahes viisil kolmandatele isikutele avaldada. Juhul, kui Te olete saanud käesoleva e-kirja eksituse tõttu, teavitage sellest koheselt saatjat ning kustutage e-kiri.
This e-mail and any attachments transmitted may contain confidential and privileged information.  If you are not the intended recipient, please notify the sender immediately by returning the e-mail and permanently deleting what you have recieved. Any dissemination or use of this information by a third person without permission is prohibited and may be illegal.

Dear Colleagues,

I hope my email finds you well!

My name is Irena Milobratovic and I am the owner of the company Indaea (Registration Number: 17019274) & Principal Consultant. 

I will be representing the client from the US as a European Authorised Representative in the EU.  

Thus, as an Estonian company, I would like to check with you if there is a national procedure/notification step to the Estonian NCA.

If this is the case, could you please guide me on local requirements and on how to perform this step?

The Device is Class I, an antibacterial herbal dental oral solution.

Thank you so much for your support, and all the best,

Irena

I wish you a joyful, healthy, and prosperous New Year!