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Küsimused
Ravimiamet · 20. veebruar 2025
- Viit
- MSO-1/841-1
- Registreeritud
- 20. veebruar 2025
- Dokumendi liik
- Sissetulev kiri
- Adressaat
- Malta Medicines Authority
- Saabumis/saatmisviis
- e-post
- Funktsioon
- MSO Meditsiiniseadmed
- Sari
- MSO-1 Eesti ja Euroopa Liidu ametiasutuste vaheline meditsiiniseadmetega seotud kirjavahetus
- Toimik
- MSO-1/2025
- Vastutaja
- Maarika Ojala (RA, Meditsiiniseadmete osakond)
Sisu (failidest)
Saatja: Gatt Baldacchino Elaine at Medicines Authority <[email protected]>
Saaja: Grech Louise 1 at Medicines Authority, Farrugia Karen at Medicines Authority, Medical Devices at Medicines Authority
Teema: 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