Last May, the European (EU) Council published its position on the draft regulations for Medical Devices and IVD. Despite not being the final version, the position of the EU Council provides some insight and a better understanding of the regulation to be discussed by the “Constitutional Triangle” composed of the EU Commission, Parliament and Council. The final adoption of the new regulation is expected to significantly revamp the current EU Directives regulating Medical devices (MD) and In vitro Diagnostics (IVD).
The topics covered include:
- The state of the EU regulations and the processes it entails
- The evolution of the EU IVDD.
- Possible classification changes and the corresponding pathway for CE Marking
- Potential impacts for IVD manufacturers