Küsimused
| Dokumendiregister | Ravimiamet |
| Viit | MSO-1/841-1 |
| Registreeritud | 20.02.2025 |
| Sünkroonitud | 21.02.2025 |
| Liik | Sissetulev kiri |
| Funktsioon | MSO Meditsiiniseadmed |
| Sari | MSO-1 Eesti ja Euroopa Liidu ametiasutuste vaheline meditsiiniseadmetega seotud kirjavahetus |
| Toimik | MSO-1/2025 |
| Juurdepääsupiirang | Avalik |
| Adressaat | Malta Medicines Authority |
| Saabumis/saatmisviis | Malta Medicines Authority |
| Vastutaja | Maarika Ojala (RA, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
| Taotle dokumendi eemaldamist või parandamist |
Failid
From: Gatt Baldacchino Elaine at Medicines Authority <[email protected]>
Sent: Fri, 14 Feb 2025 12:54:14 +0000
Cc: Grech Louise 1 at Medicines Authority <[email protected]>; "Farrugia Karen at Medicines Authority" <[email protected]>; "Medical Devices at Medicines Authority" <[email protected]>
Subject: MDR Article 59 Derogation for Androcor NV
Dear Colleagues,
We have received an application for a MDR Article 59 Derogation for Arterial Cannulae Reinforced, Aortic Catheter, Flex Line Venous Catheter and Flex Line Two Stage Venous Catheter manufactured by Andocor NV, Belgium.
The rationale for the application is supply shortages and lack of alternatives. May you kindly indicate whether you use alternatives for the above mentioned medical devices and what these alternatives are?
Thank you and kind regards,
Elaine
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Küsimused | 20.02.2025 | 1 | MSO-1/841-2 | Väljaminev kiri | ra | Malta Medicines Authority |