Evaluation procedures for in vitro diagnostic medical devices
Information
Type
Miscellaneous
Regulated products
IVDMD, Medical Devices
Topics
Notified Bodies
Last updated
February 20, 2023
Description
As of May 26, 2022, Regulation (EU) 2017/746 (IVDR) of the European Parliament and of the Council, repealing Directive 98/79/EC and Commission Decision 2010/227/EU, is applicable with some exceptions. On September 28, 2022, Legislative Decree No. 138 of August 5, 2022 on the adaptation of national legislation to the provisions of the Regulation entered into force. Legislative Decree August 5, 2022 , No. 138 repeals with some exceptions Legislative Decree September 8, 2000 , No. 332. It is allowed to place on the market and put into service in the Italian territory in vitro diagnostic medical devices bearing the CE marking that demonstrates their compliance with Legislative Decree 332/2000 and allows their free movement within the EU (Article 110 of Regulation (EU) 2017/746 "Transitional Provisions"). At the end of the transitional period, in vitro diagnostic medical devices can be made available on the market or be put into service only if they comply with Regulation (EU) 2017/746.
Tags
Organization
Country / Region
Italy
License
Creative Commons Attribution 3.0