Küsimused

Dear Richard

Thank you for the inquiry.

I would like to specify that in essence we do not give out approvals for distribution. We require a notification of device distribution in Estonia. This obligation comes from our national Medical Devices Act §26 section 4 which states that:

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 (OJ L 189, 20.07.1990, p 17–36) or Council Directive 93/42/EEC concerning medical devices (OJ L 169, 12.07.1993, p 1–43) 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 State Agency of Medicines thereof within 10 days after distribution of the relevant medical device for the first time.

In short – you only have to notify us of device distribution once and within 10 days after distributing the device for the first time. After the device has been entered into the database we do expect that you keep the data in our database up to date. For example if the devices are covered by a Certificate and the old one expires, a new Certificate is released resulting in the manufacturer issuing a new Declaration of Conformity we would strongly recommend that you update the data (if necessary) and upload the new documents to our database as well.

I hope this clarifies the situation for you. Should you have any further questions, please don’t hesitate to contact us again.

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140

www.ravimiamet.ee

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Hello,

I would like to request for some information related to the medical devices approved for distribution in Estonia.

Do these approvals have an expiry date or is the approval for an unlimited time?

Thanks in advance!

Best regards,

Richard Osogo
Quality & Compliance Director

+358 40 173 0144

www.finndent.com

Läkkisepäntie 23, 00620, Helsinki, FINLAND

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