Kiri

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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