Differing national interpretations of the IVD (in vitro diagnostic) Directive will test manufacturers' ability to comply
This article was originally published in Clinica
Executive Summary
The Medical Devices Directive was supposed to create a single European regulatory environment for such products throughout the European Economic Area. But differences in the way individual health authorities have transposed it mean that in practice requirements for manufacturers can vary considerably from country to country. The same will be true of the In Vitro Diagnostics Directive, which has technically just come into force. Maureen Kenny reports.
You may also be interested in...
Deal Watch: AbbVie Teams With MedinCell On Long-Acting Injectables
Collaboration Edition: Including deals involving Evotec/Variant, Sanofi/IGM/Nurix, ABVC/OncoX and Harmony/Bioprojet, along with tech transfer agreements and deals in brief.
GE HealthCare Launches AI-Powered Voluson Ultrasound For Women’s Health
Voluson Signature 20 and 18 ultrasound provides clinicians with workflow efficiencies in detecting female reproductive health problems, especially those related to pregnancy.
CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings
FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.