Kiri

Dear Ingelise,

This assumption was made because the initial inquiry was regarding a diagnostic test, and you addressed us as the competent authority for medical devices in Estonia, responsible for corresponding inquiries regarding medical devices and IVDs.

In your letter, you now mention that it is actually a medicinal product. If it is indeed a medicinal product, you should address your question to the Agency of Medicine, as they are competent to answer requirements related to medicines. Additionally, please provide documents (package, labelling, instructions for use) regarding the product in question so that we can understand what product it is.

Best regards,

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[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.

Dear Mr. Türk,

Thank you for your reply. We don’t fully understand why you qualify our prick test as a medical device. In all other EU jurisdictions it is qualified as a medicinal product. It is certainly not for self-use.  The prick test needs to be applied by a General Practitioner or a medical specialist. Does this clarify my previous questions? We wish to know whether it is allowed to have Balti Intermed sell our prick test which is registered in Germany with a label and a leaflet in the German language. If required, we can provide a digital translation of the leaflet. The prick test may not be relabelled by adding a label in the Estonian language.

Looking forward to your swift reply to the foregoing. Thank you in advance for your time and cooperation!

Kind regards,

Dear Ingelise,

Thank you for your inquiry.

When distributing IVD devices in Estonia, distributors must fulfil the general obligations of distributors as stated in EU Regulation 2017/746.

One of the obligations of a distributor (Article 14(2)(b)) is to verify that the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10 (10).

Article 10 (10) of IVDR states the following:

Manufacturers shall ensure that the device is accompanied by the information set out in Section 20 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient. The information supplied in accordance with Section 20 of Annex I with devices for self-testing or near-patient testing shall be easily understandable and provided in the official Union language(s) determined by the Member State in which the device is made available to the user or patient.

Language requirements for medical devices in Estonia can be found in Medical Devices Act § 16 (3) and it is written as following:

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.

To put it briefly, if the prick test is intended for a lay person, all materials including the IFU and packaging must be in Estonian.

Also, if the prick test in question is compliant with the IVDD 98/79/EC and has a transition period according to article 110 (3), it must meet the requirements set in Directive 98/79/EC.

If so, I would like to point out Annex I 8.1 of the IVDD: The decision whether to translate the instructions for use and the label into one or more languages of the European Union shall be left to the Member States, except that, for devices for self-testing, the instructions for use and the label must include a translation into the official language(s) of the Member State in which the device for self-testing reaches its final user.

Additionally, there is a distribution notification requirement for certain IVD devices that are placed on the market under IVDR in Estonia it is based on Estonian Medical Devices Act § 26 (4) which says:

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 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.

The distribution notification can be done through Estonian Medical Device Database (EMDDB, https://msa.sm.ee/).

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, e-mail and the position in the company.

Documents needed with the notifications of IVD devices are following: Declaration of conformity, EC certificate, instruction for use in English, instruction for use in Estonian and copy of the labelling or packaging.

NB! Please note that the access to the database is limited to users outside of Estonia.

In case of this, please contact with [email protected] with an request to access to the database and your IP address. They will white-list your IP and you should have an access to the database.

This is a temporary restriction for security reasons which hopefully will be removed in near future.

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

Best regards,

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[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.

Dear Mr Türk,

I would like to ask you some questions regarding a diagnostic (prick test) which HAL Allergy would like to import in Estonia:

1. HAL Allergy intends to sell a German registered and German labelled diagnostic (prick test) in Estonia. Is this allowed under Estonian law and, if so, on what legal basis? Could you please provide me with the English text of the relevant legislation?

2. Also, the leaflet for this diagnostic is currently in the German language. Is it required or allowed to provide our Estonian distributor by email with a translation of the official leaflet in the Estonian language  (in pdf format), which the distributor can in turn provide (by email) to all customers (pharmacies, hospitals with a pharmacy)?

I appreciate receiving your swift answer.

Kind regards,

This e-mail and any files transmitted with it may contain confidential information, and is solely intended for the addressee. If you have received this message in error, please notify the sender immediately by e-mail or telephone and delete the e-mail and any transmitted files without reading, copying or disclosing its contents to any other person. Any unauthorized disclosure of the contents of this e-mail and any files transmitted with it to other persons is prohibited. HAL Allergy Group does not accept any liability for unauthorized disclosure of the content of this e-mail and any transmitted files to third parties, mutilations to the content, or damage resulting from the use of the content of this e-mail and any transmitted files..

This e-mail and any files transmitted with it may contain confidential information, and is solely intended for the addressee. If you have received this message in error, please notify the sender immediately by e-mail or telephone and delete the e-mail and any transmitted files without reading, copying or disclosing its contents to any other person. Any unauthorized disclosure of the contents of this e-mail and any files transmitted with it to other persons is prohibited. HAL Allergy Group does not accept any liability for unauthorized disclosure of the content of this e-mail and any transmitted files to third parties, mutilations to the content, or damage resulting from the use of the content of this e-mail and any transmitted files..