Kiri

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.

Dear colleagues,

In December 2023, the Greek CA received an application from AbbVie
Pharmaceuticals S.A. on behalf of Smiths Medical ASD, Inc, USA, (EAR:
Smith’s Medical Czech Republic a.s.) to grant a derogation under Article
59 of the Regulation (EU) 2017/745  for the device "CADD-Legacy Duodopa
pump, Model 1400".

According to the information provided, CADD-Legacy Duodopa Pump Model
1400 is the only specialized device for the delivery of the medicinal
product DUODOPA ENT.GEL (20+5)MG/ML to aPD patients. No alternative
medicinal product in this pharmaceutical form is available in Greece at
the moment.  The device  was CE Certified under MDD (CE 669121 from BSI
2797,  exp.date 18/03/2023) but the CE will not be renewed under MDR.  
AbbVie  Inc. who is the MAH for the medicinal product DUODOPA ENT.GEL
(20+5)MG/ML and also the European customer for CADD-Legacy Duodopa
Pump,  is developing  a new ambulatory infusion pump as a replacement
device with a new device partner. The application for certification
under MDR  is anticipated to be submitted to the Notified Body  BSI,
within 2024.

The MF Smith’s Medical ASD Inc. has submitted a derogation request to
continue to market the product  CADD-Legacy Duodopa Pump Model 1400 
until MDR certification of the replacement device is achieved (foreseen
for the Q2/2026).

In this regard, we would like to know if you have received any
derogation requests or already granted derogation for the CADD-Legacy
Duodopa Pump, Model 1400 manufactured by Smiths Medical ASD, Inc, USA
and if you have information about the use of the CADD-Legacy Duodopa
Pump, Model 1400  or about any alternative treatments implemented in
your country.

Thank you very much for your collaboration.

Kind regards,

Virginia Safra

--

Με εκτίμηση,
Βιργινία Σαφρά
Αν. Προϊσταμένη Τμήματος Αξιολόγησης Υγειονομικού Υλικού ΕΟΦ
Μεσογείων 284, 155 62 Χολαργός
Tel.+30 213 20 40 407

Kind regards,
Virginia Safra
Deputy Head of the Medical Devices Assessment Section
National Organization for Medicines (EOF)
284, Mesogeion Ave, 15562
Athens, Greece
Tel.+30 213 20 40 407



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