Kiri

Dear Sietske and colleagues good-morning,

Thank you very much for you help and for the information provided which is very much appreciated.  According to Abbvie Hellas  a similar Derogation request, at the moment, has been submitted only to Switzerland  and is also under assessment.

A modified application for certification under MDR of the new ambulatory infusion pump has been submitted to the Notified Body  BSI on 13/3/24.  MDR certification  is expected at the end of 2026.

Thank you all who have responded to our enquiry.

Kind regards,

Virginia Safra

Dear Virginia,

 

Please find the respond to our questions from ICU Medical:

 

“This pump model is manufactured under the Smiths Medical name but is exclusively distributed by AbbVie.

 

ICU medical can confirm that the MDD certification for this pump model has expired and wey will not be transitioning the device to MDR certification.  The pump model was historically placed on the EU market under valid MDD certification but as certification has now expired the pump is unable to be placed on the EU market unless supported by a derogation.  CADD Legacy Duodopa pumps placed on the EU market prior to certificate expiry continue to be used by clinical centres across Europe. 

 

We understand from Abbvie that there continues to be a clinical demand for supply of additional pumps in Greece and this is why a derogation has been requested in Greece.  As the local distributor in Greece, AbbVie submitted the application to EOF with the support and agreement of Smiths Medical/ICU Medical.  We are not aware of a clinical demand for this pump model in The Netherlands and AbbVie have informed us that they do not foresee a need for a similar derogation in The Netherlands.”

 

Kind regards,

 

Sietske Eerens

Senior Inspector
........................................................................
Medical Technology, team vigilance

Dutch Health and Youth Care Inspectorate (IGJ)

Ministery of Health, Welfare and Sport
P.O. Box 2518 | 6401 DA Heerlen | The Netherlands
........................................................................
T +31 (0)88 1205000
[email protected]

https://english.igj.nl/

Twitter @IGJnl| LinkedIn IGJ

..........................................

Clear. Fair. Independent.

..........................................

Confidential documents can be securely sent through: https://igj.rijkscloud.nl, thereby addressing [email protected] t.a.v. Sietske Eerens

 

 

 

 

 

-----Oorspronkelijk bericht-----
Van: Eerens, S.T. (Sietske)
Verzonden: vrijdag 15 maart 2024 08:38
Aan: 'Meditsiiniseadmed (Medical Devices)' <[email protected]>; ΣΑΦΡΑ ΒΙΡΓΙΝΙΑ <[email protected]>; Cyprus Medical Devices Authority <[email protected]>; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; IGJ medische technologie <[email protected]>; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]
CC: _Dienstpostbus IGJ Meldpunt <[email protected]>; IGJ medische technologie <[email protected]>
Onderwerp: RE: Derogation request for CADD-Legacy Duodopa Pump Model 1400 MF: Smith’s Medical ASD Inc., USA

 

Dear Viginia,

 

The Netherlands didn't receive a derogation request for the  CADD-Legacy Duodopa Pump Model 1400 from AbbVie Pharmaceuticals S.A. on behalf of Smiths Medical ASD, Inc, USA.

However we do think it is a strange request, since Smits Medical is taken over by ICU Medical, we do not understand the request from AbbVie Pharmaceuticals S.A.

I have contacted the RA manager of ICU medical to get some more information regarding this derogation request.

As soon I have got more information I share it with you.

 

Kind regards,

 

Sietske Eerens

Senior inspector

M +31 (0)615035571

 

[email protected]

 

........................................................................

Medical Technology, team vigilance

 

Dutch Health and Youth Care Inspectorate (IGJ) Ministry of Health, Welfare and Sport P.O. Box 2518 | 6401 DA Heerlen | The Netherlands ........................................................................

T +31 (0)88 1205000

F +31 (0)88 1205001

Email [email protected]

https://english.igj.nl/

Twitter @IGJnl | LinkedIn IGJ

..........................................

Clear. Fair. Independent.

..........................................

Confidential documents can be securely sent through: https://igj.rijkscloud.nl, thereby addressing [email protected] t.a.v. Sietske Eerens

 

 

 

 

 

 

-----Oorspronkelijk bericht-----

Van: Meditsiiniseadmed (Medical Devices) <[email protected]>

Verzonden: maandag 11 maart 2024 13:13

Aan: ΣΑΦΡΑ ΒΙΡΓΙΝΙΑ <[email protected]>; Cyprus Medical Devices Authority <[email protected]>; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; Meditsiiniseadmed (Medical Devices) <[email protected]>; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; IGJ medische technologie <[email protected]>; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]

Onderwerp: Vs: Derogation request for CADD-Legacy Duodopa Pump Model 1400 MF: Smith’s Medical ASD Inc., USA

 

Dear Virginia,

 

Thank you for your notification and enquiry.

 

The Estonian competent authority has not received derogation request for the CADD legacy Duodopa pump, Model 1400 manufactured by Smiths Medical ASD, Inc, USA.

 

 

However we found this device in our medical device database. We marked the entry in the medical device database as expired and informed the distributor that there were no valid legal documents.

 

In addition, a possible alternative was recently registered in our database, but we cannot say that it is a similar device. This device can be found at the link below.

 

https://msa.sm.ee/ctrl/en/MeditsiiniSeade/andmed/20177

 

Kind regards,

Maarika Ojala

Chief Specialist

Department of Medical Devices

+372 5400 4028

[email protected]

 

Republic of Estonia

Health Board

+372 794 3500

[email protected]

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

 

This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.

 

 

 

-----Algsõnum-----

Saatja: ΣΑΦΡΑ ΒΙΡΓΙΝΙΑ <[email protected]>

Saatmisaeg: kolmapäev, 6. märts 2024 14:12

Adressaat: Cyprus Medical Devices Authority <[email protected]>; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; Meditsiiniseadmed (Medical Devices) <[email protected]>; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]

Teema: Derogation request for CADD-Legacy Duodopa Pump Model 1400 MF: Smith’s Medical ASD Inc., USA

 

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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-- 
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