Vastuskiri

Dear Emilia Adamczyk

Thank you for contacting us.

First let me point out that the obligation to notify us about distribution only applies to those IVD devices that have been placed on the market under the IVDR (regulation 2017/746). For IVD devices still on the market under the directive the notification can be made voluntarily.

From the Estonian Medical Devices Act § 26:

(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.

Secondly, on the language requirements. The language requirements apply to devices regardless of the obligation to notify about distribution – meaning that the requirements still have to be met even if the nofification is not mandatory. According to the Estonian MDA the devices intended for professional use can be marketed with IFU in English only. However, I will point out that the Estonian Language Act also applies and can be umderstood to give the professional user the right to recieve information in Estonian. Therefor we suggest to confirm with the professional user that they do not require the IFU in Estonian.

For notifications you can add a note to the application regarding the missing Estonian IFU to expedite the process. Or the person processing the application will ask for clarification if anything is unclear for them.

I hope this has been helpful, do get back to us with any additional questions.

Best regards

Piret Põiklik 

Head of Department

Department of Medical Devices

Phone +372 5853 3610

[email protected] | [email protected]

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Dear All,

Could you please be so kind and clarify Language requirements for notification in vitro medical devices in Estonia?

Our products are intended for use by professionals. According to ET law it is allowed to put on the market such products with English IFU.

Could you please confirm how notify such products as one of the required documents which should be uploaded to data base is IFU in Estonian language? In case of products for professional users can we submit the notification without ET IFU? Should we submit as an attachment statement/justification why ET translation is missing?

Thank you,