If you are a manufacturer, an Authorized Representative, an importer or distributor, you will most likely receive further instructions from the European Union on the implementation of the MDR (EU) 2017/745 and IVDR (EU) 2017/746 Regulations that entered in force on May 26, 2017.
As the transition periods of these Regulations are about to end, the European Commission in collaboration with the Medical Devices Coordination Group (MDCG) issued five Guidance Documents to support economic operators.
The aforementioned documents are shown below:
- A checklist focusing on the manufacturer’s obligations according to MDR (EU) 2017/745 and IVDR (EU) 2017/746:
Exhaustive list of requirements for manufacturers of Medical Devices
- Step by step instructions for Medical Devices and IVDs that describe the activities carried out to facilitate the implementation of the two Regulations:
Step by step implementation model for Medical Devices Regulation
Step by step implementation model for in-vitro diagnostic Medical Devices Regulation
- Factsheets for Medical Devices and IVDs manufacturers providing an overview of the Regulations changes and the implementation timeframes:
Factsheet for manufacturers of in-vitro diagnostic Medical Devices
Factsheet for manufacturers of Medical Devices
For more information:
