Vastuskiri

Dear Sabina,

 

Thank you for your inquiry. I believe I am the right contact for your questions.

 

It seems to me that I have already answered the current inquiry in the previous letters, but repetition is not bad if it helps to clearly understand the requirements.

 

So, Regulation (EU) 2017/745 on Medical Devices (MDR) is directly applicable in Estonia, as it is in the entire EU.

Additionally, national legislation, the Medical Device Act, contains legal provisions that are left to decide of the member state by the MDR.

 

One particular and very relevant for you Medical Device Act § 41², that regulates the period when EUDAMED is not fully functional as required by the MDR article 33*. The wording of the Medical Device Act § 41² is as follows:

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

Until the implementation date of the obligations set out in points d and e of subsection 3 of Article 122 of Regulation (EU) 2017/745 and in points a and f of subsection 3 of Article 113 of Regulation (EU) 2017/746 of the European Parliament and of the Council related with the European database on medical devices, the exchange of information with the Health Board and the transmission of data to the Health Board takes place according to the wording of the Medical Devices Act in force prior to entry into force of this wording.

The previous 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.

 

The placing the device on the market notification can be done through Estonian Medical Device Database (EMDDB, https://msa.sm.ee/).

As an E-resident of Estonia you are able to log into the database using national secure authentication method for e-services.

 

Documents with the notifications of medical devices are following: Declaration of conformity, instruction for use and copy of the labelling or packaging.

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 notification successfully in the database.

 

If the notification in the national database is successful, you are free to voluntarily register your devices in EUDAMED as well.

 

I would suggest familiarizing yourself with the Medical Device Act as a whole to not miss anything important.

 

*- As there was a recent proposal for a gradual roll-out of EUDAMED, it may change the process. However, as it is currently still a proposal, and the national legislation has not changed, the process of placing a class I medical device on the market in Estonia remains as written.

 

If you have any further questions, feel free to ask.

 

Best regards,

 

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[email protected] | [email protected] 

 

Republic of Estonia Terviseamet | 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: 1M4 UG - QM <[email protected]>
Saatmisaeg: neljapäev, 1. veebruar 2024 17:26
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: Re: New request for e-consulting

 

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

 

Dear Karl,

I trust this message finds you well.

Thank you once again for the wealth of information you've shared with us thus far. We are eager to initiate the registration process and have accordingly completed the information below. Since I am unsure about the appropriate contact person, I am reaching out to you with the hope that you can direct it to the relevant department or individual. Your assistance in this matter is highly valued.

Subject: Inquiry on Registration Process for Medical Products in Estonia

I am reaching out to you as our team is currently in the process of establishing a company in Estonia through the E-Residency program. Our business activities span various fields, including the development and production of medical products, along with consultancy services related to the Medical Device Regulation (MDR). It has come to our attention that we need a business license for medical devices as a wholesaler and must register these products with your organization.

Introduction:
Our global core team consists of two individuals with 40 and 25 years of experience in medical device manufacturing and distribution, respectively. We also have an engineer with approximately 6 years of product development experience and a Person Responsible for Regulatory Compliance (PRRC) expert with over 15 years of regulatory and quality assurance experience. Additionally, we have a quality control specialist based in China. The products are manufactured on our behalf in China by corresponding manufacturers who also produce these Class I products for other companies. While our current company is located in Germany, we plan to relocate to Estonia due to its favorable business environment for a globally dispersed team. Our director is scheduled to relocate to Estonia later in 2024.

Current Portfolio:
Our existing portfolio comprises approximately 15 low-risk Class I medical products, currently listed with German authorities. All products are intended for use by medical experts only. With the imminent closure of our German company, we will soon delist these products. Additionally, we have upcoming products in the pipeline, all falling under Class I medical devices according to MDR. While our primary market currently lies in Germany, Austria, and Switzerland, our products are also distributed in other EU countries. We do not sell directly to end customers but through distributors, who subsequently supply other medical supply companies.

Inquiry:
We would greatly appreciate it if you could provide information on the process of registering medical products in Estonia and outline the necessary requirements. Additionally, please specify the information, documents, or certificates required for this process.

Your guidance is invaluable to us, and any advice you can provide would be highly appreciated.

Kind regards,

 

Sabina

 

1M4 UG (haftungsbeschränkt)
Strandweg 16
17213 Untergöhren - Deutschland
[email protected] - www.1m4.de

Steuer-Nr..: 075/108/94923
USt-IdNr.: DE323762513
Handelsregister HRB 20890
Amtsgericht Neubrandenburg
Sitz der Gesellschaft: Untergöhren
Geschäftsführer: Roland Ortloff

 

 

Am Mi., 10. Jan. 2024 um 08:36 Uhr schrieb Meditsiiniseadmed (Medical Devices) <[email protected]>:

Dear Sabina,

 

2024 has started off busy. I hope you're having a great start to the year too.

Also thank you for the additional questions.

 

A Certificate of Free Sales is a document for the purpose of exporting medical devices outside of the European Economic Area. For example, there are some third-world countries that rely on the CE marking and want to ensure that CE-marked devices are legally placed on the market in the EU. You do not need this document to sell medical devices in the EU.

 

I am confident that you could request such a document as a manufacturer of authorized representative from the German Competent Authority if your business is located in Germany. The basis of the Certificate of Free Sale is Article 60 of the MDR and our national legislation that you are referring to specifies the details of the Certificate of Free Sales.

The fee for the Certificate of Free Sales can be found in State Fees Act § 298² and is as follows:

A state fee of 154 euros is paid for the issue of a certificate of free sale within 45 days after the submission of the application.

 (2) A state fee of 32 euros is paid for the issue of a duplicate of a certificate of free sale.

 (3) A state fee of 308 euros is paid for the issue of a certificate of free sale within five working days after the submission of the application at the request of a person.

 

I am not sure if you are talking about the same document when referring to the TÜV SÜD certificate, as the Certificate of Free Sale can only be issued by the Competent Authority. TÜV SÜD is a notified body that can issue QMS and product-specific certificates.

 

The old Medical Device Act § 26 (1) as you referred to, is still valid as the EUADMED is not yet fully functional, and implementing provisions, as stated in the current Medical Device Act § 41², apply.

 

Hopefully, I answered all the questions.

 

Best regards,

 

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[email protected] | [email protected] 

 

Republic of Estonia Terviseamet | 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: 1M4 UG - QM <[email protected]>
Saatmisaeg: teisipäev, 9. jaanuar 2024 18:04
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: Re: New request for e-consulting

 

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

 

Dear Karl,

 

I hope you are well and had a good start to 2024!?

 

I checked your answer in the meantime and in this regard I have a new question:

 

https://www.riigiteataja.ee/en/eli/ee/515032023005/consolide/current

How does the "Certificate of Free Sale" work and what does it cost?

 

 

 

Do I understand it correctly, that the registration of class I products in the estonian system, creating the whole technical documentation incl. CE certificate is not sufficient to sell within the EU? So do we need this Free Sale certificate as well to deliver the medical devices to other EU countries?

 

According to PRRC (article 15 MDR 2017/745): I made the seminar some years ago and the certificate is only in German. It is from TÜV SÜD. I´m waiting for their answer if the certificate is available in English as well. If that is not possible, do you need an official translation of the certificate?

 

Medical Device Act: § 26 changed. So is this part still required? Or can I ignore the timeline with the 10 days?

 

Thanks again for your help!

 

Best regards,

Sabina

 

1M4 UG (haftungsbeschränkt)
Strandweg 16
17213 Untergöhren - Deutschland
[email protected] - www.1m4.de

Steuer-Nr..: 075/108/94923
USt-IdNr.: DE323762513
Handelsregister HRB 20890
Amtsgericht Neubrandenburg
Sitz der Gesellschaft: Untergöhren
Geschäftsführer: Roland Ortloff

 

 

Am Mo., 18. Dez. 2023 um 14:43 Uhr schrieb Meditsiiniseadmed (Medical Devices) <[email protected]>:

Dear Sabina,

 

Indeed, Estonian is the official language used by the authorities, but I would say that most communications can be done in English. For instance in case of medical devices there are some fields in the notification form that need to be in Estonian – device name and intended use.

 

I would suggest familiarizing yourself with the Medical Device Act in general and finding sections where only Estonian is required.

One other particular instance where Estonian is definitely required is in inspection reports and related protocols in the case of market surveillance activities – these documents are only available in Estonian. Therefore, there must be a readiness to understand documents in Estonian.

 

I understand that this is not the current question (or is?), but I want to be clear on that as well. The language requirements for medical devices placed on the market, made available, distributed, and put into service in Estonia are also specified in the Medical Devices Act § 16 (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.

 

Above mentioned becomes relevant when you plan to sell medical devices in Estonia, not solely as the manufacturer located in Estonia, but also as an active participant in the Estonian market.

 

If you have any further questions, feel free to ask.

 

Best regards,

 

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[email protected] | [email protected] 

 

Republic of Estonia Terviseamet | 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: 1M4 UG - QM <[email protected]>
Saatmisaeg: esmaspäev, 18. detsember 2023 13:21
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: Re: New request for e-consulting

 

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

 

Dear Karl,

 

Thanks a lot for your quick reply.

 

Since Estonian is obviously the official language, is all communication with the authorities- in regards to medical supplies - in Estonian only or is English acceptable as well?

 

Thanks again. Your help is very much appreciated!

Best regards

Sabina

 

1M4 UG (haftungsbeschränkt)
Strandweg 16 
17213 Untergöhren - Deutschland
[email protected] - www.1m4.de 

Steuer-Nr..: 075/108/94923 
USt-IdNr.: DE323762513 
Handelsregister HRB 20890 
Amtsgericht Neubrandenburg 
Sitz der Gesellschaft: Untergöhren 
Geschäftsführer: Roland Ortloff

 

 

 

Meditsiiniseadmed (Medical Devices) <[email protected]> schrieb am Mo. 18. Dez. 2023 um 09:13:

Dear Sabina,

 

Thank you for your inquiry.

 

Here are the answers to your questions:

 

• Where do we have the company as manufacturer, including PRRC?

 

If the plan is to place devices on the EU market under your new Estonian company name, you will need to establish an Estonian company, as Kristi has previously guided you. There are no country-specific rules or requirements for appointing a PRRC. General PRRC principles apply as seen in the MDCG 2019-7.

 

• Do you need a certificate / proof of training for PRRC?

 

Please see the aforementioned MDCG guidance – these principles apply.

 

• Where do we have to register the medical devices? Eudamed is still not fully working.

 

Until EUDAMED is not fully functional, the placing on the market for class I devices goes through the national Medical Devices and Appliances Database, as stated in the Medical Device Act § 41²:

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

 Until the implementation date of the obligations set out in points d and e of subsection 3 of Article 122 of Regulation (EU) 2017/745 and in points a and f of subsection 3 of Article 113 of Regulation (EU) 2017/746 of the European Parliament and of the Council related with the European database on medical devices, the exchange of information with the Health Board and the transmission of data to the Health Board takes place according to the wording of the Medical Devices Act in force prior to entry into force of this wording.

 

The previous 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.

 

• In which language do you need the technical documentation? Is English ok or do you need it in Estonian?

 

English is accepted as the language for technical documentation.

 

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] 

 

Republic of Estonia Terviseamet | 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: 1M4 UG - QM <[email protected]>
Saatmisaeg: laupäev, 16. detsember 2023 12:53
Adressaat: Karl Kalev Türk <[email protected]>
Teema: Fwd: New request for e-consulting

 

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

 

Hello Karl!

 

I got your contact details from Kirsti (see below).

 

We - 1M4 UG - are a small company and sell/produce some medical and non-medical products. These are produced mostly in China and Pakistan, but we are the manufacturer of the medical devices. They are class I, so no notified body is needed.

 

We think about moving the company to Estonia. Could you please give me some advice like:

 

Where do we have the company as manufacturer, including PRRC?

Do you need a certificate / proof of training for PRRC?

Where do we have to register the medical devices? Eudamed is still not fully working.

In which language do you need the technical documentation? Is English ok or do you need it in Estonian?

 

Any advice you can give me according to MDR and this topic would be helpful for our decision.

 

Thank you very much!

 

Best regards

Sabina

 

1M4 UG (haftungsbeschränkt)
Strandweg 16 
17213 Untergöhren - Deutschland
[email protected] - www.1m4.de 

Steuer-Nr..: 075/108/94923 
USt-IdNr.: DE323762513 
Handelsregister HRB 20890 
Amtsgericht Neubrandenburg 
Sitz der Gesellschaft: Untergöhren 
Geschäftsführer: Roland Ortloff

 

 

------- Weitergeleitete Nachricht ------
Von: Kirsti Priivits <[email protected]>
Datum: Fr. 24. Nov. 2023 um 13:11
Betreff: New request for e-consulting
An: 1M4 UG - QM <[email protected]>

 

Hallo Sabina,

 

Danke für Deine E-Mail und ich habe gleich verstanden, dass ein Termin noch in dieser Woche zu finden, schwierig sein wird.

Ich bin nächster Woche unterwegs  - erst in Österreich und dann in Finland. Ich schlage vor, dass wir unser Intro in Dezember machen.

 

Doch kann ich gerne gleich einige Informationen teilen (auf Englisch, ich hoffe, dass es auch so passt):

 

First I am covering the topic of steps to take for establishing a company:

Holders of an Estonian ID card or e-Residency card and a growing number of EU member states’ ID cards can establish a Private Limited Company fully online. If an ID or e-Residency card is not available, a visit to a notary in Estonia is needed to verify the foundation documents.
Establishing a private limited company – as easy as ABC:

1. Choose a name for your business and check that it is available. To check the availability, use the free tool on the website of the e-Business Register.
2. If the management board of your Estonian company is located abroad, you will need a designated contact person in Estonia, as required by the Commercial Code. This service can be obtained from a virtual office service provider. Only a notary, notary’s office, advocate, law office, sworn auditor, audit firm or licensed trust and company service provider may be designated as your contact person. A reliable source for finding business service providers is the e-Residency Marketplace, where only companies with the necessary operating license are added. If one of the management board members, a partner, a shareholder or a procurator of your company resides in Estonia, this person may also be designated as a contact person.
3. Register the company online at the e-Business Register. You can pay the state fee (in most cases 265 €) and share capital (from 0.01 € per shareholder) when you submit your application.
4. Receive confirmation. Your submitted application will be reviewed in up to one working day and any notifications will be sent by e-mail.
5. If / when your company has employees, register the employees in the employment register on the website of the Tax and Customs Board.
6. If the area of activity is subject to special requirements, a license has to be acquired. Information on the areas of activity and electronic registration on the website of the Register of Economic Activities.
7. If needed, register the company as a VAT payer on the website of Tax and Customs Board.

Though the process is fairly simple, specialized service providers (private companies) can help you through the steps. If using e-Residency, read suggestions how to choose a service provider and what services they can help you with.

 

I contacted Terviseamet (Estonian Health Board) and recieved advice to forward You directy to them. Please contact Karl Kalev Türk [email protected] to arrage a meeting.

Some information in english can be found here: Contacts: Medical Devices | Government installation profile (terviseamet.ee). There is a Medical Device Act in English available.

 

If You have any other questions, please let me know and let’s arrange intro in December.

 

 

Best regards,

 

Kirsti Priivits

Deputy Head of Global Business Development

Invest Estonia

Enterprise Estonia

 

+372 501 2063

[email protected]

Sepise 7, 11415 Tallinn

 

Building a successful Estonia!

 

 

Facebook: EAS – Enterprise Estonia

LinkedIn: EAS – Enterprise Estonia

 

From: 1M4 UG - QM <[email protected]>
Sent: Tuesday, November 21, 2023 5:25 PM
To: Kirsti Priivits <[email protected]>
Subject: Re: New request for e-consulting

 

Hallo Kirsti,

Danke für deine schnelle Rückmeldung. Morgen und übermorgen passt es bei mir leider nicht.

Aber ich melde mich, sobald ich etwas Puffer habe!

 

Gibt es denn allgemeine Infos, die ich vorab erhalten kann?

Vielen Dank!

 

Herzliche Grüße

 

Sabina

 

1M4 UG (haftungsbeschränkt)
Strandweg 16
17213 Untergöhren - Deutschland
[email protected] - www.1m4.de

Steuer-Nr..: 075/108/94923
USt-IdNr.: DE323762513
Handelsregister HRB 20890
Amtsgericht Neubrandenburg
Sitz der Gesellschaft: Untergöhren
Geschäftsführer: Roland Ortloff

 

 

Am Di., 21. Nov. 2023 um 15:52 Uhr schrieb Kirsti Priivits <[email protected]>:

Hallo Sabina,

 

Danke für deine E-Mail und Interesse in Estland dein Unternehmen zu gründen.

Ich bin Kirsti Priivits, verantwortlich für DACH Region in unserem Team.

 

Ich würde gerne eine Intro machen, uns vorstellen und von Dein Unternehmen und von Deine Pläne hören.

 

Wie würde Dir morgen, am Mittwoch um 13.00 EET oder am Donnerstag um 10.00 EET passen?

 

 

Freundliche Grüsse,

 

Kirsti Priivits

Deputy Head of Global Business Development

Invest Estonia

Enterprise Estonia

 

+372 501 2063

[email protected]

Sepise 7, 11415 Tallinn

 

Building a successful Estonia!

 

 

Facebook: EAS – Enterprise Estonia

LinkedIn: EAS – Enterprise Estonia

 

See elektronkiri võib sisaldada konfidentsiaalset informatsiooni. Kui antud kiri ei ole suunatud Teile, siis selle avaldamine, kopeerimine, levitamine või muul viisil kasutamine on rangelt keelatud ning võib olla ebaseaduslik. Kui saite selle kirja ekslikult, palun teavitage sellest koheselt kirja saatjat ning kustutage kiri oma süsteemidest.

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