Kiri

Dear Sam,

Thank you for your enquiry.

In Estonia, medical devices and medicines are located in different institutions. Therefore, we, the Estonian Health Board, who are the competent authority for medical devices, are responsible for addressing them.

Here are the answers to your questions:

• Does the manufacturer need to submit a notification prior to placing their device on the Estonian Market?

There is a distribution notification requirement in Estonia which is based on Estonian Medical Devices Act § 26 (4) (https://www.riigiteataja.ee/en/eli/ee/524012023001/consolide/current) which says:

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 or Council Directive 93/42/EEC concerning medical devices 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 Health Board thereof within 10 days after distribution of the relevant medical device for the first time.

The distribution notification can be done through Estonian Medical Device Database (EMDDB, https://msa.sm.ee/).

Therefore, the notifications are mainly for distributors, but in the case of direct distribution from the manufacturer, the manufacturer shall also notify us about the distribution.

If we are talking about Estonian manufacturers or ARs located in Estonia, then they have an obligation to notify us of placing the class I medical device or IVD medical device on the market 10 days in advance until EUDAMED is mandatory. This also can be done through the same aforementioned national database.

• Do they still need to submit the notification if they are registered on EUDAMED?

The distribution notification is separate from the EUDAMED registrations. As you may know, there are no distributors in EUDAMED listed, meaning there is no information what devices are made available in Estonia and by who. This information is necessary for us to conduct effective market surveillance.

• Can the Authorized Representative submit the notification on behalf of the manufacturer?

If there is a PoA to represent the company, then yes.

Please do not hesitate to contact me for further information or any questions.

Best regards,

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[email protected] | [email protected] 

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Dear State Agency of Medicines,

We trust this email finds you well.

We are an authorised representative based in Malta and we represent a number of medical device manufacturers all over the world. We are aware that in some EU countries, such as Italy,  the manufacturer will have to submit a notification or register their device on a national database prior to placing the medical device on the national market.

Our questions are the following;

• Does the manufacturer need to submit a notification prior to placing their device on the Estonian Market?

• Do they still need to submit the notification if they are registered on EUDAMED?

• Can the Authorized Representative submit the notification on behalf of the manufacturer?

We look forward to hearing from you and taking you in advance for your time.

Wishing you a fantastic week ahead.

Kindest Regards,