The IVD directive, to which all in-vitro diagnostic test manufacturers must comply by 7 December 2003, states that CE marking must be displayed on all tests sold within Europe
In order to comply with the forthcoming EU in vitro diagnostics (IVD) directive, Remel Europe, a manufacturer and world-wide distributor of microbiology and laboratory diagnostic tests, has announced that it has been registered by the Medicines and Healthcare products Regulatory Agency and has met all the requirements set out by the IVD directive well head of deadline. The IVD directive, to which all in-vitro diagnostic test manufacturers must comply by 7 December 2003, states that CE marking must be displayed on all packing and in pack literature for diagnostics tests sold within Europe.
Martin Lacey, quality assurance and regulatory affairs manager at Remel commented: "This is a great achievement for Remel Europe.
"The Dartford factory only began operating in January this year and so we came into the time frame quite late.
"We became registered for the CE mark in April this year, just four months into operation, and now, having updated all of our packaging and labels for CE mark, as well as instructions for use which have been translated and printed in six different languages, we are fully compliant well ahead of the deadline".
