Vastuskiri

Dear Marta,

No, there is no specifically formulated sentence provided by us on the matter of incidents reporting obligation. So, it can be in free format, the main thing that this information is presented.

Dear Sofia, 

Thank you for the valuable insight!

We have an additional question regarding MDR Annex I Chapter III 23.4. (z):

According to this point, it is mandatory to add information to the IFU on where to report incidents related to the medical device. 

In this case, we are wondering if you have a specific sentence formulation (legally compliant) for this sentence on how the reports shall be made to Tervisaemet (or any other competent authority). If so, could you please provide it in Estonian?

For example, in Latvian we use 'about any incident or potential indicent related to the use of a medical device, the user of the device must notify the State Medicines Agency within three days after the accident, as well as must inform the manufacturer'.

Your prompt reply will be highly appreciated!

Market Access Lead

www.carolpharma.eu

tālr./phone: +371 28605514

TAILOR MADE PHARMACEUTICAL SOLUTIONS

Regulatory Affairs. Translations. Pricing and Reimbursement. Food Supplements.

From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Date: 18 March 2024 at 13:58:05 EET
To: Karlina Jurjeva <[email protected]>
Subject: Vs: Medical devices packagings and labels in Estonia



Dear Karlina,

 

In general, we are following all the provisions laid down in MDR and IVDR Regulations, including packaging, labels ad IFU requirements. Additional requirements are set up in national Medical Devices Act § 16 point 3, they concern language issues and read as follows:

 

(3) The manufacturer, relying on risk analysis, ascertains the information necessary for the safe use of a device for the intended purpose, and the information related with a medical device placed on the market, made available on the market, distributed and put into service in Estonia must be presented:
 1) in the Estonian language and in an appropriate manner if the medical device is intended for the use of lay users;
 2) in the Estonian or English language and in an appropriate manner if the medical device is intended only for the use of professional users;
 3) in the language understandable to a specific user and in an appropriate manner in case of a custom-made medical device.

 

What concerns distribution, please keep in mind, that accordingly to Medical Devices Act § 26 point 4, there is notification obligation set up depending on risk class of distributed devices:

 

(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 Health Board thereof within 10 days after distribution of the relevant medical device for the first time.

 

Notification can be made via Medical Device Database - https://msa.sm.ee/eng  

 

If you are using database for the first time, under Forms you can find a short guide, how to use the database - https://msa.sm.ee/eng/form

 

Hope this information was helpful enough. In case of any additional questions do not hesitate to contact us again.

 

Best regards,

 

Sofia Ratušnaja

Chief Specialist 

Medical Devices Department

+372 5661 5491

[email protected] | [email protected] 

  

 

Republic of Estonia

Health Board

+372 794 3500

[email protected] 

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

 

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.

 

Saatja: Karlina Jurjeva <[email protected]>
Saatmisaeg: esmaspäev, 11. märts 2024 10:54
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Koopia: Gerda Putnina <[email protected]>; Marta Silavniece <[email protected]>
Teema: Medical devices packagings and labels in Estonia

 

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.

 

To whom it may concern,

 

I am writing to clarify if the IFU (patient leaflets), packagings and labels of medical devices are to be applied the same terms and requirements as in Latvia, namely, they are subject to the Regulations 2017/745,  2017/746? Or are there any additional requirements from Estonian national authority.

 

 We have an array of medical devices that we would like to distribute also in Estonia.

 

Thank you very much in advance for your answer,

 

Respectfully,

 

Karlīna Jurjeva

Executive director

 

www.carolpharma.eu

tālr./phone: +371 26465788

 

TAILOR MADE PHARMACEUTICAL SOLUTIONS

 

Regulatory Affairs. Translations. Pricing and Reimbursement. Food Supplements.