Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.3-1/24/633-9 |
| Registreeritud | 08.02.2024 |
| Sünkroonitud | 27.03.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.3 Meditsiiniseadmete alane koostöö Euroopa komisjoni, sõsarasutuste, ministeeriumide ja teiste ametite/inspektsioonidega |
| Sari | 11.3-1 CA-de ja EL (sh EK) töörühmade kirjavahetus ja dokumendid (sh Eesti esitatud plaan, kokkuvõte, dokumendid; EK plaanid, kokkuvõtted) |
| Toimik | 11.3-1/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Danish Medicines Agency |
| Saabumis/saatmisviis | Danish Medicines Agency |
| Vastutaja | Maarika Ojala (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: Narin Amin <NARA@dkma.dk>
Sent: Wed, 07 Feb 2024 07:20:58 +0000
To: "mso@terviseamet.ee" <mso@terviseamet.ee>
Subject: SV: Derogation Survey (EE)
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Maarika Ojala
Thank you for sending the derogation survey.
We are trying to answer the survey, however it seems as if the link to the survey cannot be accessed.
Will you try to send me the link again?
Kind regards,
Narin Amin
Specialkonsulent, Cand.jur.
Special Advisor
T (dir.) +45 51845748
Lægemiddelstyrelsen
Center for Kontrol, Medicinsk Udstyr & Tilgængelighed
Centerjura
Danish Medicines Agency
Centre for Control, Medical Devices & Availability
Centre Legal Services
T +45 44 88 95 95
Fra: Meditsiiniseadmed (Medical Devices) <mso@terviseamet.ee>
Sendt: 16. januar 2024 09:23
Til: 'medizinprodukte@basg.gv.at'; 'coen.meddev@fagg-afmps.be'; 'medical@bda.bg'; 'farmaceutska.inspekcija@miz.hr'; 'medpro@halmed.hr'; 'cymda@mphs.moh.gov.cy'; 'coen@sukl.cz'; Med-udstyr <Med-udstyr@dkma.dk>;
'coen@fimea.fi'; 'alertes@dgccrf.finances.gouv.fr'; 'dmcdiv@ansm.sante.fr'; 'coen@zlg.nrw.de'; 'market-surveillance@eof.gr'; 'medicaldevices@eof.gr'; 'medtech@igj.nl';
amd@ogyei.gov.hu; 'medicaldevices@ima.is';
devices@hpra.ie; 'market.surveillance@sanita.it'; 'vi@vi.gov.lv';
medical.devices@llv.li;
vaspvt@vaspvt.gov.lt; 'meddevices@ms.etat.lu'; Medisinsk utstyr <medisinsk.utstyr@legemiddelverket.no>;
daps@infarmed.pt; 'mdevice@anm.ro'; 'coen@sukl.sk'; JAZMP MP_SFI <MP_SFI@jazmp.si>;
JAZMP Meddev <meddev@jazmp.si>; 'pscontrol@aemps.es'; 'registrator@lakemedelsverket.se'; 'tibbicihaz.pgd@titck.gov.tr'; 'SANTE-COEF-ADMIN@ec.europa.eu';
Medical Devices at Medicines Authority <devices.medicinesauthority@gov.mt>; Katja Mohorčič <Katja.Mohorcic@jazmp.si>;
incydenty@urpl.gov.pl;
medical.devices@swissmedic.ch
Emne: Derogation Survey (EE)
Dear Colleagues,
Given the complexity of dealing with derogations from the conformity assessment procedure established with Article 59 of the MDR (EU) 2017/745 and Article 54 of the IVDR (EU) 2017/746, we would like to conduct a survey among competent authorities.
We prepared the survey to gather information on the two types of derogations - national and compassionate/single patient use derogation. Additionally, we would also like to ask some general questions.
Our aim for this study would be to facilitate the derogation process and update our national procedures for granting derogations.
The survey will be open until 11th of February and can be accessed here:
https://ec.europa.eu/eusurvey/runner/EEDEROSurvey2023
Please take the time to fill in the questionnaire, we would be very grateful if you could provide one answer for your country and if necessary forward this link to any colleagues who are best suited to answer.
If you have any questions, please do not hesitate to ask and send an email to mso@terviseamet.ee
We will make the results of the survey available after analysis.
Kind regards,
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
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.
