Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.3-1/24/10974-1 |
| Registreeritud | 31.10.2024 |
| Sünkroonitud | 01.11.2024 |
| 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 | SANTE F MEDICAL DEVICES |
| Saabumis/saatmisviis | SANTE F MEDICAL DEVICES |
| Vastutaja | Piret Põiklik (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
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Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Nomination of national experts in the field of medical devices - Ares(2024)7747645 (Please use this link only if you are an Ares user – Svp, utilisez ce lien exclusivement si vous êtes un(e) utilisateur d’Ares)
Dear Heads of Service,
I am writing to you in order to request confirmation of nominations of national experts who would be available for joint assessments in the field of medical devices, as per Article 40 of Regulation (EU) 2017/745 (MDR) and Article 36 of Regulation (EU) 2017/746 (IVDR).
Joint assessments and subsequent designations and re-assessments of notified bodies are key to ensure effective implementation of the Regulations as well as availability of devices and a high level of patient safety thereof. Under the Regulations, joint assessments are a joint responsibility for the Commission and Member States. The role of national experts is pivotal for the conduct of the joint assessment process.
We would be grateful if you could confirm the national experts from your country that will be available to carry out joint assessments in 2025 to the corresponding functional mailbox ([email protected]) as soon as possible and, in any case, no later than 10 December 2024. On nomination please provide the following information relating to each nominated expert:
(i) Name and work e-mail address
(ii) Regulation to which the nomination refers (MDR, IVDR or both)
(iii) The experts’ corresponding curricula, as well as information on their specific qualifications with regard to type of devices and areas of knowledge.
Note that the above information is required for each nomination (even if it has been provided in the past) as personal details are not kept on file from previous years.
Due to the number of upcoming re-assessments, we would appreciate if you could also explore the possibility of nominating additional experts who would be available to participate in joint assessment teams in 2025.
Kind Regards,
Máiréad
Máiréad Finucane
European Commission
Health & Food Safety Directorate General (DG SANTE)
Directorate F – Health and food audits and analysis
Unit F.5 (Health Protection)
Grange, Dunsany, Co. Meath, Ireland
Tel: +353 46 9061 950
E-mail: [email protected]
