Custom-made devices and Regulation (EU) 2017/745
Information
Type
Miscellaneous
Regulated products
Medical Devices
Topics
Custom-Made Medical Devices
Last updated
July 12, 2024
Description
As of May 26, 2021, the Regulation (EU) 2017/745, which entered into force on May 25, 2017, applies to custom-made medical devices in a harmonized manner in all member states. The Legislative Decree of August 5, 2022, No. 137 adapts national legislation to the provisions of the regulation and regulates custom-made medical devices in Article 7.
Tags
Organization
Country / Region
Italy
License
Creative Commons Attribution 3.0