| Dokumendiregister | Terviseamet |
| Viit | 11.3-1/24/633-16 |
| Registreeritud | 29.05.2024 |
| Sünkroonitud | 30.05.2024 |
| 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 | Health Products Regulatory Authority Ireland |
| Saabumis/saatmisviis | Health Products Regulatory Authority Ireland |
| Vastutaja | Maarika Ojala (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
From: Donal O'Connor <[email protected]>
Sent: Wed, 29 May 2024 10:49:58 +0000
To: "[email protected]" <[email protected]>
Cc: MSO <[email protected]>
Subject: RE: EE Derogation survey results
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Maarika,
I am the clinical manager for devices at the HPRA and responsible for the team that review derogation applications.
Firstly, thank you to you and your colleagues for arranging, summarising and sharing the results of this survey. We were very happy to participate and provide responses as we are very interested in this topic at the HPRA.
Secondly, I am preparing a CAMD short talk on article 59 derogations to be delivered in June. HPRA proposed this short talk as we feel , as is reflected in some of the comments on your slides, that there should be greater visibility and consistency regards expectations on derogation process between MSs.
If it is ok with you, I would like to make to make reference to your survey results , including some of the future plan comments. I would of course fully acknowledge the work Estonia conducted to generate and analyse the survey.
Look forward to your response and also HPRA would be happy to share any further details on our national derogation process.
Kind regards,
Donal
Mr. Donal B O’Connor
MB BCh BAO, MA, MD, FEBS (General Surgery)
Clinical Manager - Medical Devices
Health Products Regulatory Authority | An tÚdarás Rialála Táirgí Sláinte
Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2.
Tel: +353 1 634 3542 - direct line
Fax: +353 1 676 7836
MCRN 272391
From: Meditsiiniseadmed (Medical Devices) <[email protected]>
Sent: Tuesday, April 2, 2024 11:20 AM
To: '[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]'; HPRA Medical Devices Mailbox <[email protected]>;
'[email protected]'; '[email protected]'; [email protected];
[email protected]; '[email protected]'; Medisinsk utstyr <[email protected]>;
[email protected]; '[email protected]'; '[email protected]'; JAZMP MP_SFI <[email protected]>;
JAZMP Meddev <[email protected]>; '[email protected]'; '[email protected]'; '[email protected]';
'[email protected]'; Medical Devices at Medicines Authority <[email protected]>;
Katja Mohorčič <[email protected]>;
[email protected];
[email protected]
Subject: EE Derogation survey results
|
CAUTION: This email originated from outside the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe. |
Dear Colleagues,
We would like to thank the 18 countries that participated in the derogations survey organised by the Estonian competent authority.
The responses to the survey are crucial for us to enhance national derogations procedures and develop forms.
We are pleased to share the results of the survey.
Please find the attached file with the results.
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.
Saatja: Maarika Ojala <[email protected]>
Saatmisaeg: reede, 2. veebruar 2024 08:30
Adressaat: '[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]'; Medisinsk utstyr <[email protected]>;
[email protected]; '[email protected]'; '[email protected]'; JAZMP MP_SFI <[email protected]>;
JAZMP Meddev <[email protected]>; '[email protected]'; '[email protected]'; '[email protected]';
'[email protected]'; Medical Devices at Medicines Authority <[email protected]>;
Katja Mohorčič <[email protected]>;
[email protected];
[email protected]
Teema: REMINDER Invitation to participate in a survey on derogations (national and compassionate/single patient use)
Dear colleagues,
We would like to keep you updated on the progress of the study on derogations and reiterate our call for your participation.
In particular, we would like to thank the 7 countries that have already responded.
The survey is open until 29.02.2024 and we hope that more colleagues will find the time to fill in the questionnaire:
https://ec.europa.eu/eusurvey/runner/EEDEROSurvey2023
We would be very grateful if you could pass this link on to those colleagues who deal with derogations.
If you have any questions, please do not hesitate to ask and send an email to [email protected]
Best 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.
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Health Products Regulatory Authority Kevin O'Malley House Earlsfort Centre Earlsfort Terrace Dublin 2 Tel + 353 1 676 4971 www.hpra.ie
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