НАЙДИТЕ СЛЕДУЮЩИЙ ШАГ
Найдите помощь по всей Финляндии.
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Medicines Education Portal
Показать связи →The Medicines Education Portal is an info package on the use of medicines. It contains study modules and task ideas for basic education teachers.
Издатель: Fimea · Государственная организация
Язык описания: Английский
Охват: Вся Финляндия
Об услуге
Описание
The Medicine Education Portal contains study modules and plenty of task ideas for basic education teachers. The Portal is a good information package on the use of medicines for everyone. In the TroppiOppi section for schoolchildren, you can play TroppiOppi or test your health knowledge. The contents of the Medicines Education Portal are checked regularly and updated when needed. The contents are designed for different age groups by grade.
Где и как получить помощь
В этом срезе нет связанного канала обращения. См. официальную страницу услуги ниже.
Посмотреть услугу на Suomi.fi →
Notification of a clinical investigation with medical devices
Показать связи →All clinical investigations with medical devices under the MD Regulation must be notified to Fimea or be subject to an authorization request.
Издатель: Fimea · Государственная организация
Язык описания: Английский
Охват: Вся Финляндия
Об услуге
Описание
According to Regulation (EU) 2017/745, ‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a medical device. The requirements set out in Chapter I of Annex XV to the MDR apply to all clinical investigations of medical devices.
Fimea must be notified of all clinical investigations conducted with medical devices that fall under the MDR. You must apply to Fimea for authorisation for most investigations. Some investigations are processed through a notification procedure.
* If the clinical investigation is conducted with a non-CE marked medical device or with a CE-marked medical device outside the scope of its intended purpose AND the results of the investigation will be used in the conformity assessment, you must apply to Fimea for authorisation of the clinical investigation under Article 62 of the MDR.
* If the results of the investigation will not be used in the conformity assessment of the investigational device (e.g investigator-driven research using a CE-marked device or an early pilot phase investigation with a non-CE marked device), you must apply to Fimea for an authorisation under Article 82 of the MDR. More detailed provisions on investigations under Article 82 have been set out in the Act 719/2021 (Finlex) and Fimea’s Administrative Regulation 1/2022 (Finlex, in Finnish).
* In the case of a post-market follow-up investigation involving additional invasive and/or burdensome procedures, you must notify Fimea of the investigation under Article 74(1) of the MDR. If the description given in Article 74(1) does not apply, the investigation may be in accordance with Article 82.
You can find more information about different regulatory pathways in document: MDCG 2021-6.
Начало сбора 2026-10-10T21:11:51.293Z · Опубликовано 2026-10-11T12:19:37.711Z . Сведения каталога могут меняться; они не отражают пропускную способность услуг и не являются рекомендацией.