TUV Rheinland - a clarification:
This article was originally published in Clinica
Executive Summary
TUV Rheinland's application for notified body status under the In Vitro Diagnostics Directive (IVDD) will be made in collaboration with the UK Central Public Health Laboratory (CPHL) directly, rather than with the UK National Institute for Biological Standards and Controls (NIBSC) as reported in Clinica No 871, p 3. The NIBSC is not part of the CPHL. The NIBSC - a public health laboratory - is currently negotiating a contract with an unnamed third party testing and certification organisation to apply for notified body status under the IVDD.