Vastuskiri

Dear Pablo de Mingo Monge,

Thank you for your enquiry.

National law for medical devices in Estonia is Medical Devices Act. Estonian Medical Device Act regulates these parts of the EU Regulation 2017/745 on medical devices and EU Regulation 2017/746 on in vitro diagnostic medical devices that are left to decide for the EU member states (e.g. language requirements, distribution notification).

Distribution notification is mandatory only for higher risk class devices - 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 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/).

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.

Please note that the professional user still has the right to demand the information in Estonian (national Language Act). The professional user still has the right to demand that the information accompanying the device be supplied in Estonian. Information supplied only in English should be agreed upon prior to the sale of the device.

Essential requirements regarding information supplied with the device are laid down in Annex I Chapter III article 23 of the MDR and article 20 of the IVDR.

You also might find useful the following EU regulations on electronic instructions for use of medical devices - Regulation (EU) 207/2012 and Regulation (EU) 2021/2226.

Feel free to contact us with any further questions you may have.

Best regards,

Egle Audova

Chief Specialist

Department of Medical Devices

Phone +372 5566 7596

[email protected] | [email protected]  

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Dear Madam/Sir,  

I hope this email finds you well.  

I am writing to you on behalf of Obelis s.a., European Authorized Representative based in Belgium. We would highly appreciate if you could answer the below questions concerning the national implementation of the MDR – Regulation (EU) 2017/745 and IVDR – Regulation (EU) 2017/746. 

Firstly, would you please confirm that :

• Estonia: Medical Devices Act

are the laws applicable to medical devices on your territory? May I ask you if the national law implementing the IVDR was already published? As after thorough research, we are unable to identify it.

Secondly, under MDR & IVDR and until EUDAMED is fully functional, is a national registration needed before placing a device on your market?  

·        For which risk classes specifically it has to be performed?   

·        Can we as EAR based in Belgium do it on behalf of the Manufacturer or distributor – on top of the notification we perform to our competent (Belgian) Authority?  

Thirdly, concerning the labelling: 

·        Would you please confirm that labels & IFUs must be translated in the national language and that English is permitted only for devices for professional use?  

·        Do MDR/IVDR legacy devices need to meet same requirements? 

·        Would you consider acceptable that only IFUs are uploaded on the manufacturer’s website? Or do labels have to be uploaded as well?  

Thank you very much in advance for your valuable help.  

Best regards,

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