Notified Bodies in Italy for conformity assessment
Information
Type
Miscellaneous
Regulated products
IVDMD, Medical Devices
Topics
Notified Bodies
Last updated
July 18, 2024
Description
As of November 26, 2017, provisions are applicable regarding Bodies wishing to operate under Regulation (EU) 2017/745, in the medical device sector, and under Regulation (EU) 2017/746, in the in vitro diagnostic medical device sector. Notified Bodies designated under the previous Directives are no longer allowed, as of May 26, 2021, for medical devices and as of May 26, 2022, for in vitro diagnostic medical devices, to issue new certificates. However, the Notified Body that legitimately issued a certification, prior to May 26, 2021 for medical devices or May 26, 2022 for in vitro diagnostic medical devices, shall continue to be responsible for the oversight of the devices it has certified.
Tags
Organization
Country / Region
Italy
License
Creative Commons Attribution 3.0