Kiri

Dokumendiregister Terviseamet
Viit 11.1-12/24/2445-3
Registreeritud 04.03.2024
Sünkroonitud 26.03.2024
Liik Sissetulev dokument
Funktsioon 11.1 Turustamise järgne järelevalve (post-marketing surveillance)
Sari 11.1-12 Turujärelevalvega seotud muu kirjavahetus („tahetakse infot“) - Nõustamine
Toimik 11.1-12/2023
Juurdepääsupiirang Avalik
Juurdepääsupiirang
Adressaat BD group
Saabumis/saatmisviis BD group
Vastutaja Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond)
Originaal Ava uues aknas

Failid

RE_ National rule on reprocessing of single use devices in Estonia.msg
image004.jpg

From: Barbara Björkbom <Barbara.Bjoerkbom@bd.com>
Sent: Mon, 11 Sep 2023 07:51:06 +0000
To: "Meditsiiniseadmed (Medical Devices)" <mso@terviseamet.ee>
Subject: RE: National rule on reprocessing of single use devices in Estonia

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.


 

Dear Karl,

 

Thank you for the info and link that is very useful and provide a clear information about the reprocessing of single use.

 

 

In regards of refurbish (to restore and/or refurbish a medical device to the original specifications) if it is possible to commercialized in Estonia aa reconditioned medical device?

 

 

I thank you for your support!

 

 

Best regards,

 

Barbara Björkbbom

 

From: Meditsiiniseadmed (Medical Devices) <mso@terviseamet.ee>
Sent: Monday, September 11, 2023 9:11 AM
To: Barbara Björkbom <Barbara.Bjoerkbom@bd.com>
Subject: Vs: National rule on reprocessing of single use devices in Estonia

 

Dear Barbara, Thank you for your letter. Reprocessing of single-use devices (MDR article 17) is not allowed in Estonia. I am not sure whether you are aware, but information about national rules on reprocessing single-use devices is also made

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Dear Barbara,

 

Thank you for your letter.

 

Reprocessing of single-use devices (MDR article 17) is not allowed in Estonia.

 

I am not sure whether you are aware, but information about national rules on reprocessing single-use devices is also made available on the European Commission website - https://health.ec.europa.eu/medical-devices-topics-interest/reprocessing-medical-devices/national-rules-reprocessing-single-use-devices_en

 

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

karl.kalev.turk@terviseamet.ee | mso@terviseamet.ee 

 

Republic of Estonia

Terviseamet | Health Board

+372 794 3500

info@terviseamet.ee
www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.

Saatja: Barbara Björkbom <Barbara.Bjoerkbom@bd.com>
Saatmisaeg: reede, 8. september 2023 11:43
Adressaat: Meditsiiniseadmed (Medical Devices) <mso@terviseamet.ee>
Teema: National rule on reprocessing of single use devices in Estonia

 

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.


 

 

Dear Sir/Madam,

 

 

I contact you because I would like to know if there is any national rule on reprocessing of single use devices in Estonia and if would be accepted the commercialization/shipment of remanufactured products?  if so is there is any document required for notification of remanufactured products  (specific labeling/specific post market surveillance for remanufactured products?

 

I am not aware if  it is not authorized reprocessing of single-use devices (medical and in vitro diagnostic devices)  on your  territory, and if this coming in the local legislation.

 

Can you kindly advice?

 

Thank you

 

Best regards,

 

 

/Barbara Björkbom

 

 

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