The In Vitro Medical Device (IVD) Directive was published in December 1998 and the first CE marked IVDs were placed on the market from June 2000. Until 7th December 2003 it was still possible to place IVDs on the market without CE-marking, it will also be possible to continue to sell devices that were placed on the market before 7th December 2003.

From 7th December 2005 only CE marked devices can be put into service, it is our intention to CE mark appropriate products irrespective of these dates. There is however some confusion regarding what must (or can) be CE marked.

Under the terms of the Medical Devices Directive we can only CE mark products sold for specific uses. For example we can and must CE mark products such as blood collection tubes, but we need not (and indeed are not allowed to) CE mark any product for which we cannot carry out a realistic risk assessment of its use in the market place. Also we cannot CE mark any product that is deemed to be a component, this would include diagnostic vials or dropper assemblies to be used in our customer's diagnostic test kits. Such kits must be CE marked by the supplier. As we sell many items as components of other assemblies (e.g. Diagnostic Kits) it follows that some of our customers will need to CE mark their products, our duty to such customers obliges us to have available all records necessary for their purposes.

We are able to CE mark appropriate products and we feel that we need to make our customers aware of our abilities and obligations. In addition to our ISO 9001:2000 registration we are also registered to ISO 13485 (Medical Devices Quality Management Systems: 2003). The stringent requirements of this standard ensure that we have the systems, procedures and records to enable us to generate CE marking for our own products, and sufficient information or records for those customers who need to CE mark their products utilising our components.

Any customer who wishes to discuss this matter can contact our technical department on extension 222 or email richard@ls-uk.com and we shall do our best to answer your questions.