Kiri

Dear Hariharan,

From our understanding we already answered to your enquiry. Please find it attached.

Please note that from 1st of January 2023 our Medical Device Act changed, so please check it. Unfortunately until now it is only available in Estonian, but it certainly will be translated into English in the near future. Until then please use means of translation.

Best regards,

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[email protected] | [email protected] 

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Hello Sir/Madam,

This is a gentle follow-up to the below query.

Thanking you in advance.

_ _

Hariharan

Assistant Manager – MDV

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