Dokumendiregister | Terviseamet |
Viit | 11.1-12/24/6341-6 |
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 | CMC Consumer Medical Care GmbH |
Saabumis/saatmisviis | CMC Consumer Medical Care GmbH |
Vastutaja | Egle Audova (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
Originaal | Ava uues aknas |
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Thu, 13 Jun 2024 11:20:25 +0000
To: Stumper Anne <[email protected]>
Subject: Vs: Questions regarding Labelling Requirements
Dear Anne Stumper,
Thank you for this clarification. We suggest contacting the Consumer Protection and Technical Regulatory Authority at [email protected] for further assistance.
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: Stumper Anne <[email protected]>
Saatmisaeg: neljapäev, 13. juuni 2024 12:10
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: AW: Questions regarding Labelling Requirements
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Egle Audova,
we sell cotton pads and cotton buds for example (no cosmetics or medical devices). There is no EU law for those commodity items/consumer goods.
But some countries require labelling of different kind of information, and we are collecting data for the different countries.
If I put the category in deepl, I get:
Thank you for your help,
Anne Stumper
Mit freundlichen Grüßen / Best regards | |
Dr. Anne Stumper | |
E-Mail: anne.stumper@ cmc-group.de Eichendorffstrasse 12-14, 89567 Sontheim an der Brenz, Germany |
CMC Consumer Medical Care GmbH
Eichendorffstraße 12-14
89567 Sontheim / Brenz
Germany
Telephone switchboard +49 7325 9244-0
Telefax +49 7325 9244-491
www.cmc-group.de
General Managers CMC GROUP: Dr. Rainer Mangold, Holger Battling
Commercial Register of the District Court of Ulm HRB726009
Disclaimer: Der Inhalt dieser E-Mail (einschließlich etwaiger beigefügter Dateien) ist vertraulich und nur für den Empfänger bestimmt. Sollten Sie nicht der bestimmungsgemäße Empfänger sein oder diese E-Mail irrtümlich erhalten haben, ist Ihnen jegliche Offenlegung, Vervielfältigung, Weitergabe oder Nutzung des Inhalts untersagt. Bitte informieren Sie in diesem Fall unverzüglich den Absender und löschen Sie die E-Mail (einschließlich etwaiger beigefügter Dateien) von Ihrem System. Vielen Dank! Hinweise zum Datenschutz inklusive der Informationen nach Art. 13, 14 DS-GVO finden Sie hier.
Disclaimer: The contents of this email (including any attachments) are confidential and may be legally privileged. If you are not the intended recipient of this email or have received this email in error, any unauthorized disclosure, copying, distribution or use of its contents is strictly prohibited. In such case, please notify the sender immediately and then delete the mail (including any attachments) from your system. Thank you! Information on data protection including the information according to Art. 13, 14 GDPR is available here.
Von: Meditsiiniseadmed (Medical Devices) <[email protected]>
Gesendet: Donnerstag, 13. Juni 2024 10:01
An: Stumper Anne <[email protected]>
Betreff: Vs: Questions regarding Labelling Requirements
Dear Anne Stumper,
Please specify what you mean by the term "commodity item," so I can direct you to the right person. In the medical devices field we understand this term probably differently.
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: Stumper Anne <[email protected]>
Saatmisaeg: neljapäev, 13. juuni 2024 10:14
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: AW: Questions regarding Labelling Requirements
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Egle Audova,
my question is about commodity items, could you please redirect me to a responsible person or tell me, where I can find a contact person?
Thank you in advance!
Mit freundlichen Grüßen / Best regards | |
Dr. Anne Stumper | |
E-Mail: anne.stumper@ cmc-group.de Eichendorffstrasse 12-14, 89567 Sontheim an der Brenz, Germany |
CMC Consumer Medical Care GmbH
Eichendorffstraße 12-14
89567 Sontheim / Brenz
Germany
Telephone switchboard +49 7325 9244-0
Telefax +49 7325 9244-491
www.cmc-group.de
General Managers CMC GROUP: Dr. Rainer Mangold, Holger Battling
Commercial Register of the District Court of Ulm HRB726009
Disclaimer: Der Inhalt dieser E-Mail (einschließlich etwaiger beigefügter Dateien) ist vertraulich und nur für den Empfänger bestimmt. Sollten Sie nicht der bestimmungsgemäße Empfänger sein oder diese E-Mail irrtümlich erhalten haben, ist Ihnen jegliche Offenlegung, Vervielfältigung, Weitergabe oder Nutzung des Inhalts untersagt. Bitte informieren Sie in diesem Fall unverzüglich den Absender und löschen Sie die E-Mail (einschließlich etwaiger beigefügter Dateien) von Ihrem System. Vielen Dank! Hinweise zum Datenschutz inklusive der Informationen nach Art. 13, 14 DS-GVO finden Sie hier.
Disclaimer: The contents of this email (including any attachments) are confidential and may be legally privileged. If you are not the intended recipient of this email or have received this email in error, any unauthorized disclosure, copying, distribution or use of its contents is strictly prohibited. In such case, please notify the sender immediately and then delete the mail (including any attachments) from your system. Thank you! Information on data protection including the information according to Art. 13, 14 GDPR is available here.
Von: Meditsiiniseadmed (Medical Devices) <[email protected]>
Gesendet: Donnerstag, 13. Juni 2024 09:02
An: Stumper Anne <[email protected]>
Betreff: Vs: Questions regarding Labelling Requirements
Dear Anne Stumper,
Thank you for the inquiry.
The labelling requirements are set in MDR, Annex I, chapter III, 23.2.
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: Stumper Anne <[email protected]>
Saatmisaeg: teisipäev, 11. juuni 2024 13:07
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: Questions regarding Labelling Requirements
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Mr. Türk,
our company was in contact with you some time ago regarding medical devices.
Today I have a question regarding the labelling of “made in” and an expiry date for commodity items in Estonia.
Could you redirect me to the right person in charge, please?
Thank you in advance, your help is highly appreciated,
Best wishes from Germany,
Anne Stumper
Mit freundlichen Grüßen / Best regards | |
Dr. Anne Stumper | |
E-Mail: anne.stumper@ cmc-group.de Eichendorffstrasse 12-14, 89567 Sontheim an der Brenz, Germany |
CMC Consumer Medical Care GmbH
Eichendorffstraße 12-14
89567 Sontheim / Brenz
Germany
Telephone switchboard +49 7325 9244-0
Telefax +49 7325 9244-491
www.cmc-group.de
General Managers CMC GROUP: Dr. Rainer Mangold, Holger Battling
Commercial Register of the District Court of Ulm HRB726009
Disclaimer: Der Inhalt dieser E-Mail (einschließlich etwaiger beigefügter Dateien) ist vertraulich und nur für den Empfänger bestimmt. Sollten Sie nicht der bestimmungsgemäße Empfänger sein oder diese E-Mail irrtümlich erhalten haben, ist Ihnen jegliche Offenlegung, Vervielfältigung, Weitergabe oder Nutzung des Inhalts untersagt. Bitte informieren Sie in diesem Fall unverzüglich den Absender und löschen Sie die E-Mail (einschließlich etwaiger beigefügter Dateien) von Ihrem System. Vielen Dank! Hinweise zum Datenschutz inklusive der Informationen nach Art. 13, 14 DS-GVO finden Sie hier.
Disclaimer: The contents of this email (including any attachments) are confidential and may be legally privileged. If you are not the intended recipient of this email or have received this email in error, any unauthorized disclosure, copying, distribution or use of its contents is strictly prohibited. In such case, please notify the sender immediately and then delete the mail (including any attachments) from your system. Thank you! Information on data protection including the information according to Art. 13, 14 GDPR is available here.
Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
---|---|---|---|---|---|---|
Kiri | 13.06.2024 | 5 | 11.1-12/24/6341-2 | Väljaminev dokument | ta | CMC Consumer Medical Care GmbH |
Kiri | 13.06.2024 | 5 | 11.1-12/24/6341-2 | Väljaminev dokument | ta | CMC Consumer Medical Care GmbH |
Kiri | 13.06.2024 | 5 | 11.1-12/24/6341-3 | Sissetulev dokument | ta | CMC Consumer Medical Care GmbH |
Kiri | 13.06.2024 | 5 | 11.1-12/24/6341-3 | Sissetulev dokument | ta | CMC Consumer Medical Care GmbH |
Vastuskiri | 13.06.2024 | 5 | 11.1-12/24/6341-5 | Sissetulev dokument | ta | CMC Consumer Medical Care GmbH |
Vastuskiri | 13.06.2024 | 5 | 11.1-12/24/6341-5 | Sissetulev dokument | ta | CMC Consumer Medical Care GmbH |
Vastuskiri | 13.06.2024 | 5 | 11.1-12/24/6341-4 | Väljaminev dokument | ta | CMC Consumer Medical Care GmbH |
Vastuskiri | 13.06.2024 | 5 | 11.1-12/24/6341-4 | Väljaminev dokument | ta | CMC Consumer Medical Care GmbH |
Vastuskiri | 13.06.2024 | 5 | 11.1-12/24/6341-6 | Väljaminev dokument | ta | CMC Consumer Medical Care GmbH |
Kiri | 13.06.2024 | 5 | 11.1-12/24/6341-1 | Sissetulev dokument | ta | CMC Consumer Medical Care GmbH |
Kiri | 13.06.2024 | 5 | 11.1-12/24/6341-1 | Sissetulev dokument | ta | CMC Consumer Medical Care GmbH |