MDCG 2022-9: Summary of Safety and Performance Template
The MDCG have published a template for the Summary of Safety and Performance (SSP) as required by the EU IVD Regulation 2017/746 (IVDR) for Class C and Class D devices. The format of the SSP will depend on whether the device used is intended for self-testing. If it is not, then there shall be another ...
MDCG 2022-8: Application of IVDR to Legacy Devices
As most IVD manufacturers will know, a derogation to the IVDR was passed earlier this year which allows for a stepped transition in accordance with Article 110(3) of the IVDR. This allows for General IVDs registered under the IVD Directive which will require Notified Body intervention under the Regulation an extended transition period. However, there ...
MDCG 2022-7: UDI System Q&A
A Q&A document on the EU Regulation’s Unique Device Identification (UDI) system has been published to answer some of the most burning questions when it comes to the application of UDI to medical devices and IVDs. The document covers the following themes: UDI-DI. Basic UDI-DI (BUDI). UDI Labelling. UDI Rules for System and Procedure Packs ...
