Applications and notifications related to performance studies of IVD devices
Показать связи →The sponsor of a performance study shall enter and submit an application to Fimea if the study is to be conducted in Finland.
Издатель: Fimea · Государственная организация
Язык описания: Английский
Охват: Вся Финляндия
Об услуге
Описание
Performance study means a study undertaken to establish or confirm the analytical or clinical performance of a device. From 26th of May 2022 onwards, all performance studies need to be conducted according to the requirements set out in Article 57 of the IVDR. All performance studies, including performance studies using left-over samples, shall be conducted in accordance with applicable law on data protection. In certain cituations the sponsor of a performance study shall enter and submit an application following articles 58 or 70 to the Finnish national authority Fimea if the study is to be conducted in Finland. In addition to IVDR, also Finnish Act on Medical Devices (719/2021) Chapter 3 Clinical investigations and performance studies of in vitro diagnostic devices needs to be followed as applicable if the performance study is conducted in Finland.
Как пользоваться
More information about application and notification procedures can be found on Fimea’s website.
Где и как получить помощь
Performance studies of IVD-devices · Сайт
An application or notification to Fimea is required for IVD performance studies in Finland.
Описание: Английский · Языки обслуживания: Шведский, Английский, Финский
Актуальные часы работы, исключения, требования к идентификации и контакты указаны на официальной странице услуги.