IVD (in vitro diagnostic) Directive takes effect throughout the EEA (European Economic Area):
This article was originally published in Clinica
More than 18 months after the EU's In Vitro Diagnostics Directive had to take effect in the 18 member states of the European Economic Area, the process is now nearly complete. France appears to be the only country that needs to finish transposing the text, although the French healthcare products safety agency (AFSSAPS) has confirmed that the decrees needed to finalise the implementation of the directive are imminent. Belgium transposed the Directive in December.
You may also be interested in...
The FDA’s OPQ touts approval of sixth and seventh continuously manufactured drugs and quicker delivery of inspection results in latest annual report.
No device-related warning letters were released by the US FDA the week of 19 February.
Complex generics and value added medicines share common challenges on harmonization of regulation, lack of incentives and clarity of guidelines, heard delegates to Medicines for Europe’s Regulatory & Scientific Affairs conference.