EU Clarifies Requirements On Use Of Assays In The Context Of Clinical Trial Regulation
A new Q&A document clarifies the interface between the EU regulations on clinical trials and in vitro diagnostics to support the coordinated assessment of studies involving the use of diagnostic assays.
You may also be interested in...
The EU Medical Device Regulation has been in force for a year and the IVD Regulation applied a few weeks ago. Many vital guidance documents have been in the pipeline for considerable time but will be made available later this year.
This is a landmark month with the expiry this week of the IVD Directive. May has also seen a flurry of new IVD guidance documents and some serious debates over hitches encountered in the implementation of the MDR and IVDR.
A long-awaited regulation introduces major changes in the way that clinical trials are conducted across the EU, including a single application portal and new trial transparency requirements.