News of interest to medical writers: medical devices from the EC

 

The Medical Devices Special Interest Group (MD SIG) would like to let EMWA members know that lots of new documents and guidance on medical devices were recently launched on the European Commission page.


Factsheet for Authorities in non-EU/EEA States on Medical Devices and in vitro Diagnostic Medical Devices

Document date: 20/11/2018 - Created by GROW.A.1.DIR - Publication date: 20/11/2018 

 

Factsheet for Manufacturers of in vitro Diagnostic Medical Devices

Document date: 20/11/2018 - Created by GROW.A.1.DIR - Publication date: 20/11/2018 

Factsheet for Authorised Representatives, Importers and Distributors of Medical Devices and in vitro Diagnostic Medical Devices

Document date: 20/11/2018 - Created by GROW.A.1.DIR - Publication date: 20/11/2018 

Factsheet for Manufacturers of Medical Devices

Document date: 20/11/2018 - Created by GROW.A.1.DIR - Publication date: 20/11/2018 

Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) - infographics

Document date: 20/11/2018 - Created by GROW.A.1.DIR - Publication date: 20/11/2018 

Implementation Model for in vitro Diagnostic Medical Devices Regulation - Step by Step Guide 

Implementation Model for Medical Devices Regulation - Step by Step Guide

Document date: 20/11/2018 - Created by GROW.A.1.DIR - Publication date: 20/11/2018

Factsheet for the Procurement Ecosystem of Medical Devices and in vitro Diagnostic Medical Devices

Document date: 20/11/2018 - Created by GROW.A.1.DIR - Publication date: 20/11/2018 

Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices

Document date: 20/11/2018 - Created by GROW.A.1.DIR - Publication date: 20/11/2018