Kiri

Dear Sir/Madam,

Treestep Oy is a distributor for German company Implantcast GmbH in Finland. We distribute their MUTARS® tumor prosthesis system. I have received an inquiry from Tartu University Hospital if we could provide MUTARS® prosthesis for one surgery. MUTARS® system is CE marked and has been on the market for more than 25 years.

Does the product need to be registered in Estonia in order to use it or are there any other regulatory issues that need to be considered?

We are not going to start permanent distribution in Estonia. The product will be needed in one surgery only.

Best regards,  

Oskari Haanpää

Aluemyyntipäällikkö

Area Sales Manager

Kir-Fix/Treestep Oy

+358 40 901 2366

[email protected]

www.kir-fix.fi

Dear Oskari,

Thank you for your inquiry.

If the medical device is placed on the EU market properly then the distribution notification is needed for class II a, II b and III class medical devices and it can be done through Estonian Medical Device Database.

It is based on Estonian Medical Devices Act § 26 (4), 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 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 Health Board thereof within 10 days after distribution of the relevant medical device for the first time.

There is no need by law to notify us about distribution of class I or IVD medical devices, but for the market surveillance purposes we recommend to register all medical devices in EMDDB.

Registration is not dependent on the fact whether that you will or will not start permanent distribution in Estonia: one-time distribution is also distribution.

About timeframe - if everything is correct in the distribution application you will receive a notice (a pdf document) stating that this medical device is registered in the database. Usually you will receive a feedback to your application within 10 working days. This notice is not a certificate or validation of the device, just a formality.

Documents with the notifications of medical devices are following: Declaration of conformity, EC certificate, instruction for use in English, instruction for use in Estonian and copy of the labelling or packaging.

Medical devices can be registered by the manufacturer, distributor or anyone else under the POA.

The device must be properly placed on the EU market.

Please use a short guide for using the Estonian Medical Device Database that can be found on database homepage under „Forms“.

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

Best regards,

Katrin Hatšaturova

Specialist

The Department of Medical Devices

Phone +372 5331 2966

[email protected]  | [email protected]

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Dear Sir/Madam,

Treestep Oy is a distributor for German company Implantcast GmbH in Finland. We distribute their MUTARS® tumor prosthesis system. I have received an inquiry from Tartu University Hospital if we could provide MUTARS® prosthesis for one surgery. MUTARS® system is CE marked and has been on the market for more than 25 years.

Does the product need to be registered in Estonia in order to use it or are there any other regulatory issues that need to be considered?

We are not going to start permanent distribution in Estonia. The product will be needed in one surgery only.

Best regards,  

Oskari Haanpää

Aluemyyntipäällikkö

Area Sales Manager

Kir-Fix/Treestep Oy

+358 40 901 2366

[email protected]

www.kir-fix.fi