| Dokumendiregister | Terviseamet |
| Viit | 11.2-4/24/10651-1 |
| Registreeritud | 22.10.2024 |
| Sünkroonitud | 23.10.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.2 Turustamise eelne järelevalve (pre-marketing surveillance) |
| Sari | 11.2-4 Erandid vastavushindamismenetlusest, taotlused ja kirjavahetus |
| Toimik | 11.2-4/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Euroopa Komisjon |
| Saabumis/saatmisviis | Euroopa Komisjon |
| Vastutaja | Maarika Ojala (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
From: PISCOI Paul <[email protected]>
Sent: Mon, 21 Oct 2024 13:55:39 +0000
To: ABAD Carmen <[email protected]>; Alliez Emilie <[email protected]>; Alves Raquel <[email protected]>; ARADOTTIR Anna Bjorg <[email protected]>; AT <[email protected]>; AT Heidrun Eberl <[email protected]>; AT Jakob Scheruebl <[email protected]>; "AT Patrick Steinmann" <[email protected]>; AT Tamina Laimer <[email protected]>; BE Amelie Deleruelle <[email protected]>; BE Christophe Driesmans <[email protected]>; BE general <[email protected]>; BE Jeroen Poels <[email protected]>; BE Kelly Decaluwe <[email protected]>; BE Leen Duboccage <[email protected]>; BE Marco De Wolff <[email protected]>; "Berger Reinhard " <[email protected]>; Boudinova Vessela <[email protected]>; Bunyitai Peter <[email protected]>; "CARDOSO Sonia SANTOS ([email protected])" <[email protected]>; CH <[email protected]>; CH Jonas Gautschi <[email protected]>; "Charalambos Yiannakkaras ([email protected])" <[email protected]>; Cyprus <[email protected]>; "Dainiuviene Saule " <[email protected]>; Damien LAMBOT <[email protected]>; Darakchiev Todor <[email protected]>; DE <[email protected]>; DE Alexander Stein <[email protected]>; DE Andrea Feuerstack <[email protected]>; DE Anja Jacobshagen <[email protected]>; DE INes Preuth <[email protected]>; "DK Annika Herlet" <[email protected]>; DK Hinna Ahmed <[email protected]>; "DK SImon Vestergard" <[email protected]>; EGGERTSSON Haukur <[email protected]>; EL Sophia Drouska <[email protected]>; Erdelyi Annamaria <[email protected]>; ES VIGILANCIA <[email protected]>; FI Markku Mard <[email protected]>; "FI Noora Ihala" <[email protected]>; FR <[email protected]>; "FR Gwennaelle Even" <[email protected]>; FR Nacer Idriss <[email protected]>; FR Pascal Di-Donato <[email protected]>; GR <[email protected]>; "Halbauer Jochen" <[email protected]>; HR Antonela Simunovic <[email protected]>; Hratkevits Sofia <[email protected]>; IE <[email protected]>; IE - HANSON <[email protected]>; IE - MURPHY <[email protected]>; IE Emer Lahiff <[email protected]>; IE Graham Vaughey <[email protected]>; "IE Kevin Claffey" <[email protected]>; IE Pau Antichisern <[email protected]>; IS functional mb <[email protected]>; "IT Antonella Campanale" <[email protected]>; IT Daniela Minella <[email protected]>; IT functional mailbox <[email protected]>; "IT Rosa Gofredo" <[email protected]>; Josef Zuendorf - Germany <[email protected]>; JRC Aisha Sauer <[email protected]>; Kaminska Darina <[email protected]>; Kranjcec Krunoslav <[email protected]>; Lauer Wolfgang <[email protected]>; LI <[email protected]>; LI General <[email protected]>; LT VIGILANCE <[email protected]>; LV Silvija Kaugere <[email protected]>; "LV Vilnis Zvirbulis" <[email protected]>; Marliac Nathalie <[email protected]>; MD Romania <[email protected]>; Murphy Patrick <[email protected]>; NAJMANOVA Vaclavá <[email protected]>; NL authorities <[email protected]>; NL H Knol <[email protected]>; NL Helga de Graas <[email protected]>; NL Ma Schijf <[email protected]>; NO central 1 <[email protected]>; "NO central 2" <[email protected]>; NO Central 3 <[email protected]>; "NO Raymond Ludvigsen " <[email protected]>; "Nuno MORNA ([email protected])" <[email protected]>; Papaioannou Maro <[email protected]>; PISCOI Paul <[email protected]>; "PL Aleksander Wymazal" <[email protected]>; PL Joanna Rapacka <[email protected]>; PL Marcin Batory <[email protected]>; PL VIGILANCE <[email protected]>; PT VIGILANCE <[email protected]>; Ratassepp Tagne <[email protected]>; Renhardt Martin <[email protected]>; ROCHE Jean-Francois <[email protected]>; Ronald Bauer <[email protected]>; "Ruiz-Villar Carmen " <[email protected]>; Sara Angelone <[email protected]>; SE Anita Berg <[email protected]>; "SE Henrik Johansson" <[email protected]>; "SE Karl-Erik Westman" <[email protected]>; SE Magnus Akerblom <[email protected]>; SE Nina Damber <[email protected]>; SE Stina Granas <[email protected]>; SE VIGILANCE <[email protected]>; SENE Véronique <[email protected]>; Sener Olgun <[email protected]>; "SI general email" <[email protected]>; SI Urska Ocvirk <[email protected]>; Sirdey Thierry <[email protected]>; SL Maja Mlakar <[email protected]>; Stoesslein Ekkehard <[email protected]>; TAMARIT BARRULL Anna <[email protected]>; Turan Hande <[email protected]>; Ünal Adem <[email protected]>; Waelti Markus <[email protected]>
Cc: "[email protected]" <[email protected]>; Eberhard <[email protected]>; YASSIN Hanim <[email protected]>; GIORGIO Flora <[email protected]>; GOZZI Caterina <[email protected]>; BISCHOFF-EVERDING Peter <[email protected]>
Subject: FW: news with Getinge?
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Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear colleagues,
Our German colleagues kindly shared an update on Getinge, outlined below. Let us hope that we will sail through this smoothly.
Paul
MCP began with the shipping of the first HLS/PLS sets on October 2, 2024. This comprised about 245 devices, which will initially be shipped to clinics that currently have no devices in stock and have sent a request to MCP asking for individual supplies (Medical Necessity Request).
A further 800 devices can be shipped from calendar week 41. In the further course of events, MCP will aim to ensure a uniform supply throughout the EEA until the back-order situation is resolved.
MCP expects the supply situation to ease further in the near future after the internal processes have been validated. Currently, MCP is still working closely with the notified body TÜV SÜD to complete the outstanding activities.
On Wednesday the 16th of October, lawyer Wachenhausen informed us that the supply situation is tense, but it is not a situation where patients cannot be cared for. HLS and PLS sets are currently being delivered to hospitals in small quantities. The number of units depends on the hospital's inventory and the number of patients.