Küsimused

Dear Sir/Madam

I am writing on behalf of Blackford Analysis based in Edinburgh in the UK.  Blackford Analysis has a Class I software medical device CE marked under MDR.  Blackford would like to better understand the registration requirements in Estonia.  I have reviewed the information on your website regarding registration requirements in Estonia and have a few questions which I would appreciate it if you could answer.  

• * Do manufacturers based outside of Estonia have an obligation to register in Estonia prior to selling product in Estonia or does this apply to manufacturers/EC Reps located in Estonia only?

• * If a manufacturer has registered in EUDAMED, is that sufficient or is registration in Estonia required too?

• * Given Blackford are in the UK and therefore outside of the EU, please confirm it would be our authorized rep that would complete the registration if it is required?

• * Do distributors need to register in Estonia?  Does this apply to both distributors based in Estonia and those not based in Estonia?

• * Do importers need to register in Estonia?  Does this apply to both importers based in Estonia and those not based in Estonia?

• * Is registration of the product required and who carries this out (distributor, manufacturer, EC Rep)? Can you advise if the process and requirements are the same for all classifications of product?

• * Can you please advise of the registration fees which apply in Estonia?

Thanks in advance for your help

Kind Regards

Lesley