Dokumendiregister | Terviseamet |
Viit | 11.3-3/24/8991-2 |
Registreeritud | 19.09.2024 |
Sünkroonitud | 20.09.2024 |
Liik | Väljaminev dokument |
Funktsioon | 11.3 Meditsiiniseadmete alane koostöö Euroopa komisjoni, sõsarasutuste, ministeeriumide ja teiste ametite/inspektsioonidega |
Sari | 11.3-3 Üldine kirjavahetus (Koostöö riigiasutustega (ministeeriumid, ametid, inspektsioonid, jms) |
Toimik | 11.3-3/2024 |
Juurdepääsupiirang | Avalik |
Juurdepääsupiirang | |
Adressaat | Quality First International |
Saabumis/saatmisviis | Quality First International |
Vastutaja | Egle Audova (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
Originaal | Ava uues aknas |
From: "Meditsiiniseadmed (Medical Devices)" <mso@terviseamet.ee>
Sent: Thu, 19 Sep 2024 05:18:14 +0000
To: "marija.capek@qualityfirstint.com" <marija.capek@qualityfirstint.com>
Subject: Vs: [POTENTIAL PHISHING]procedures for requesting the classification of a medical device
Dear Marija Capek,
Thank you for your enquiry.
The classification of the medical device is the responsibility of the manufacturer. Estonian manufactures and authorised representatives can turn to us when they have questions related to classification or when seeking information, but as a norm we do not make classification decisions for actors. There is no additional fee for a consultation with us.
Manufacturers can find relevant guidance documents on the European Commission’s web-page, https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en , to assist the manufacturer with the classification.
Additionally, according to the Regulation (EU) 2017/745, article 51 (2), any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, shall be referred for a decision to the competent authority of the Member State in which the manufacturer has its registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State in which the authorised representative referred to in the last indent of point (b) of the second paragraph of Section 2.2 of Annex IX has its registered place of business. Where the notified body concerned is established in a Member State other than that of the manufacturer, the competent authority shall adopt its decision after consultation with the competent authority of the Member State that designated the notified body.
Best regards,
Egle Audova
Chief Specialist
Department of Medical Devices
Phone +372 5566 7596
egle.audova@terviseamet.ee | mso@terviseamet.ee
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: Marija Capek <marija.capek@qualityfirstint.com>
Saatmisaeg: esmaspäev, 9. september 2024 14:34
Adressaat: TA Info <info@terviseamet.ee>
Teema: [POTENTIAL PHISHING]procedures for requesting the classification of a medical device
Dear Sir or Madam ,
could you please let me know the procedures for requesting the classification of a medical device, the approximate processing time of a request for classification of a medical device and also the fees that apply?
Thank you, best wishes,
Marija Capek
Quality First International
Marija.capek@qualityfirstint.com
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