Saatja: RA MSO </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=72F3C63240224E00B8EFA069E66B5C58-RA>
Saaja: Gatt Baldacchino Elaine at Medicines Authority, RA MSO
Teema: Vs: MDR Article 59 Derogation for Androcor NV
Dear colleagues,
The Estonian competent authority has not been notified of any supply shortage of similar medical devices, nor have we received any request for a derogation for such devices.
For example, the following are registered in our medical devices database:
BD Arterial Cannula manufactured by Becton Dickinson Infusion Therapy Systems Inc.
Authorised representative Becton Dickinson Distribution Center NV
Of venous catheters, central venous catheters have been registered (also with antibacterial coating) manufactured by Arrow International, Inc.
Authorised representative Teleflex Medical (IE)
We don't know if this information will help you.
Kind regards,
Maarika Ojala
Specialist
Department of Medical Devices
State Agency of Medicines
[email protected] <mailto:
[email protected]>
1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140
www.ravimiamet.ee <http://www.ravimiamet.ee/>
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Saatja: Gatt Baldacchino Elaine at Medicines Authority <
[email protected]>
Saatmisaeg: reede, 14. veebruar 2025 14:54
Koopia: Grech Louise 1 at Medicines Authority <
[email protected]>; Farrugia Karen at Medicines Authority <
[email protected]>; Medical Devices at Medicines Authority <
[email protected]>
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