Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.2-4/24/5778-2 |
| Registreeritud | 05.06.2024 |
| Sünkroonitud | 06.06.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.2 Turustamise eelne järelevalve (pre-marketing surveillance) |
| Sari | 11.2-4 Erandid vastavushindamismenetlusest, taotlused ja kirjavahetus |
| Toimik | 11.2-4/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | AFMPS-FAGG |
| Saabumis/saatmisviis | AFMPS-FAGG |
| Vastutaja | Maarika Ojala (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Derogation.Meddev (AFMPS - FAGG)" <Derogation.meddev@fagg-afmps.be>
Sent: Tue, 04 Jun 2024 14:37:03 +0000
To: "Meditsiiniseadmed (Medical Devices)" <mso@terviseamet.ee>
Cc: "Damien Lambot (AFMPS - FAGG)" <damien.lambot@fagg-afmps.be>
Subject: RE: Derogation process
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Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear colleagues,
We have well received your question.
A few years ago, we used to ask for the patient’s initials on the compassionate use application form. As we sometimes receive different CU applications from the same doctor, for the same device, this allowed us to distinguish between two very similar applications.
As this is no longer possible, due to the GDPR legislation, we no longer ask for the patient’s initials (we now work with a unique reference number), but we still ask for the patient’s gender and age.
In addition, this information is also very important in determining whether or not, we can authorise a CU. Before we can approve a CU application, we need to know whether the device will be used on/for children, adults or elderly, as this may have an impact on our decision. It is also important to find relevant literature to support our decision.
Hoping this will be of service to you,
Kind regards,
Lotte Vansteelant
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Lotte Vansteelant Wetenschappelijk dossierbeheerder notifications.meddev@fagg-afmps.be
DG POST Autorisation / Division Produits de santé / Cellule Dispositifs médicaux DG POST Vergunning / Afdeling Gezondheidsproducten / Cel Medische Hulpmiddelen DG POST Genehmigung / Abteilung Gesundheitsprodukte / Stelle für Medizinprodukte DG POST Authorisation / Health Products Division / Medical Devices Entity
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agence fédérale des médicaments et des produits de santé federaal agentschap voor geneesmiddelen en gezondheidsproducten föderale agentur für arzneimittel und gesundheitsprodukte federal agency for medicines and health products
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Galileelaan 5/03 1210 BRUXELLES - BRUSSEL - BRÜSSEL - BRUSSELS T + 32 2 528 40 00
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Van: Meditsiiniseadmed (Medical Devices) <mso@terviseamet.ee>
Verzonden: maandag 3 juni 2024 9:49
Aan: Derogation.Meddev (AFMPS - FAGG) <Derogation.meddev@fagg-afmps.be>
Onderwerp: Derogation process
Dear colleagues,
We are currently working on a national (single use patsient) derogation procedure and derogation form.
Looking at the derogation forms of other Member States, we noticed that on your derogation form for a specific device(s) for a specific patient, you ask about the age category.
We would like to know, why you have decided to ask this and how it affects your decision to grant a derogation?
We would be grateful for a reply.
Yours sincerely,
Maarika Ojala
Chief Specialist
Department of Medical Devices
+372 5400 4028
Republic of Estonia
Health Board
+372 794 3500
Paldiski mnt 81, 10614 Tallinn
Estonia
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