Vastuskiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-12/24/6340-2 |
| Registreeritud | 13.06.2024 |
| Sünkroonitud | 18.06.2024 |
| Liik | Väljaminev dokument |
| Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
| Sari | 11.1-12 Turujärelevalvega seotud muu kirjavahetus („tahetakse infot“) - Nõustamine |
| Toimik | 11.1-12/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Baltrade |
| Saabumis/saatmisviis | Baltrade |
| Vastutaja | Egle Audova (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Thu, 13 Jun 2024 06:30:16 +0000
To: Britta Nylund <[email protected]>
Subject: Vs: Used medical device instruments
Dear Britta Nylund,
Thank you for the inquiry.
According to the MDR preamble (3) -this Regulation does not seek to harmonise rules relating to the further making available on the market of medical devices after they have already been put into service such as in the context of second-hand sales.
Additionally, our national Medical Device Act does not regulate second-hand devices.
Regarding question number 3, it is not specified whether you mean second-hand devices or not. If not, then the repacking and relabeling of medical devices is regulated according to MDR Article 16. This article is explained in a guidance document which you can find here: https://health.ec.europa.eu/document/download/4c7bd740-d7c3-4f7b-9a4d-249121a67b8a_en?filename=md_mdcg_2021_26_en.pdf
Please do not hesitate to contact us for further information or any questions.
Best regards,
Egle Audova
Chief Specialist
Department of Medical Devices
Phone +372 5566 7596
[email protected] | [email protected]
| Republic of Estonia Health Board +372 794 3500 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: Britta Nylund <[email protected]>
Saatmisaeg: esmaspäev, 10. juuni 2024 12:08
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Koopia: Karl Kalev Türk <[email protected]>
Teema: Used medical device instruments
Tähtsus: Kõrge
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Terviseamet,
We have received an inquiry from our supplier regarding the Estonian regulation regarding used medical devices / Instruments.
Please let me know if you can help me with the questions below.
- Are used instruments allowed on your market?
- What is the exact regulation covering the acceptance of „used“ instruments?
- What is the exact regulation covering the repacking and relabelling of medical devices?
- May used instruments be shipped into the country from another country?
- Are there any additional label requirements for used instruments on your market?
- Are there any additional requirements for used instruments on your market?
Looking forward hearing from you.
Thank you very much and best regards,
Operations & Quality Manager
+358 10 292 4632
Sipoonranta 10 B LT 1, FIN-01120 Västerskog
Finland
ISO 13485:2016 Certified
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Kiri | 13.06.2024 | 5 | 11.1-12/24/6340-1 | Sissetulev dokument | ta | Baltrade |