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Saatja: Kärolin Jenas </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=USER3064555E> Saaja: RA MSO Teema: FW: Registration Query From: Lesley Paice <[email protected]> Sent: esmaspäev, 10. veebruar 2025 14:40 To: Ravimiamet <[email protected]> Cc: David Pinto <[email protected]> Subject: Registration Query 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