EC to amend requirements for HbsAg (hepatitis B antigen) reagents:
This article was originally published in Clinica
Executive Summary
The European Commission will need to amend in the near future the EU's Common Technical Specification (CTS) on hepatitis B antigen reagents (HbsAg) in the light of international developments. CTSs are technical requirements for IVDs that are more detailed than standards and considered by regulators as quasi mandatory. The reason for the change is that the World Health Organisation (WHO) is developing the first international standard on these products, which will become the reference standard for the European CTSs. At present the EU HbsAg CTS makes reference to the French and UK standards because of the absence to date of international work in this area. Representatives of the WHO and of the European Commission's medical devices unit are due to meet during the third week of October to discuss progress. The Commission is following the work carefully and has commented that the WHO is being "open and co-operative".