Vastuskiri

Dear Hariharan,

Thank you for your enquiry.

1. There is no mandatory distribution notification requirement for class I medical devices in Estonia. For class I devices the notification can be done voluntary through Estonian Medical Device Database (EMDDB, https://msa.sm.ee/).

Distribution notification is only for higher risk class devices - Estonian Medical Devices Act § 26 (3¹) (https://www.riigiteataja.ee/en/eli/ee/524052016001/consolide/current), which says:

Any person who distributes for the first time in Estonia or puts into professional service a class II a, II b or III medical device or an active implantable medical device shall notify the Health Board thereof within ten days after distribution for the first time or putting into professional service of the device.

2. Usually the notification is done by the local distributor, but in case of direct sale, it is possible that the manufacturer does it itself. Therefore, there is no need for a local distributor.

3. Language requirements for medical devices in Estonia can be found in Medical Devices Act § 16 (3) and it is written as following: The information strictly necessary for the safe use of a medical device for its intended purpose accompanying a medical device to be placed on the market, distributed and put into service in Estonia shall be presented in the Estonian language and in an appropriate manner, taking account of the knowledge of the potential user of the device. The remaining information accompanying a device may be presented in another language of a Member State of the European Economic Area understandable to the potential user. The person who places the medical device on the market in Estonia or the distributor shall ensure the correctness of translation of the instructions of a medical device.

We interpret as if the medical device is for professional use, it is required that the information strictly necessary for the safe use of a medical device for its intended purpose is in Estonian. The remaining information accompanying a device may be presented in another language of a Member State of the European Economic Area understandable to the potential user (generally in English). We have not specified what exactly needs to be translated as it should came out of the device risk analysis and is up to a manufacturer.

If the device is for lay person, everything must be in Estonian.

As what concerns the software for professional users, we confirm that the software/device display/graphic user interface does not need to be translated into Estonian (English is acceptable) as long there is an IFU (e.g. with steps/screens) in Estonian with minimum information for safe use of a medical device for its intended purpose.

Software/GUI for lay user does not need to be translated into Estonian (English is acceptable) as long the IFU is in Estonian with all steps/screens.

Please note that a new version of Estonian Medical Device Act should come into force in the near future. It is possible to check whether the new version is available, https://www.riigiteataja.ee/en/eli/503022022001/consolide, click „Compare wordings“  and if a new version is available, it is possible to choose it.

There will be a change in the language requirements with the new version. The aim of the change is to make it more clearer (not stricter).

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] 

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Hello,

I’m Hariharan from a regulatory consulting company and a regulatory partner for a manufacturer. I have a query on the notification of the CE-marked product.

One of our clients is a manufacturer based in Poland that developed software (CE-marked under MDR, Class I) and they want to market the product in Estonia. Kindly guide us with the following queries to market the product in Estonia.

1. Do we need to do additional notification/registration to sell the CE-marked products in Estonia?

2. Should the manufacturer have a local distributor/importer for software to market the product?

3. Does the regulation have any local language preference for Software interface?

Kindly help us in understanding the requirement for marketing the device in Estonia.

Thanking you in advance.

_ _

Hariharan

Assistant Manager – MDV