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I have spoken to the MHRA on this for interpretation as it has serious consequences for the SAS. This is what I was told over the phone. The Directive does not apply to any in-house assay where it is offered to your institution/Trust. If you offer a service outside of the Trust as the SAS does then the in-house assay falls foul of the Directive and must be CE marked. I am told that we probably have most of the requirements in place for such assays in that we should have performance criteria and reference ranges. I wrote to the MHRA about 4 weeks ago asking for more information on what is required and how we should go about getting CE marking for our assays but have had no reply. Now I am back from holiday I will chase this up and will let you know of any new information. Mike Wheeler Dr Mike Wheeler Consultant Clinical Scientist Department of Chemical Pathology St Thomas' Hospital London SE1 7EH Tel: 020 7928 9292 Ext 2387 Fax: 020 7928 4226 London SE1 7EH Tell: +44 (0)171 928 9292 Ext 2387 Fax +44 (0)171 928 4226 ------ACB discussion List Information-------- This is an open discussion list for the academic and clinical community working in clinical biochemistry. Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual and they are responsible for all message content. ACB Web Site http://www.acb.org.uk List Archives http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html List Instructions (How to leave etc.) http://www.jiscmail.ac.uk/