Kiri

Dear Sir/Madam,

I am writing to inquire about the additional notification requirement for medical devices made available on the Estonian market. Specifically, I would like to know if a product manufactured by a legal entity based in the USA, with an authorized representative in the Netherlands, who has registered the products there for market access in accordance with the Medical Device Directive (MDD)/Medical Device Regulation (MDR), requires any additional notification.

Furthermore, the distributor and importer in the European Union are both located in Germany. If such notification is necessary, I kindly request detailed guidance on how to proceed with this remotely. Would it be required to obtain a login and password for the respective database, or should a national/local e-signature be established for this purpose? Additionally, could you please advise on the necessary documentation to include with the notification?

Your prompt response and guidance on this matter would be greatly appreciated.

Yours faithfully,

Aleksandra Skoczka

Regulatory Affairs Specialist EMEA

Align Technology,

Bierutowska 57-59, 51-317 Wroclaw, Poland

email [email protected]


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