Saatja: "SANTE F MEDICAL DEVICES" <
[email protected]>
Saaja:
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Teema: 2026 - Nomination of national experts in the field of medical devices - Ares(2025)9854839
Kuupäev: 2025-11-14 15:16
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu
saatja korral palume linke ja faile mitte avada.
2026 - Nomination of national experts in the field of medical devices -
Ares(2025)9854839
<https://webgate.ec.testa.eu/Ares/documentInfo/documentInfoDetailsExt.do?documentId=080166e5250741ab>
(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 2026 to the
corresponding functional mailbox (
<mailto:
[email protected]>
[email protected]) as soon as possible and, in any case,
no later than 12 December 2025. 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 2026.
We ask that you please also consider the competence required for
re-assessments (e.g. experts competent in the assessment of technical /
clinical evaluation / performance evaluation documentation reviews).
*Reminder to Heads of Service: please inform this mailbox should there be a
change of Head of Service or if any of your contact details need to be
updated.
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] <mailto:
[email protected]>