The impact of CE marking: is there a down side?
In summary, the IVDD was never intended to include in house assays produced within healthcare institutions, and it was clear to the authors that it would be impractical for them to comply with the Directive. The above points apply to all pathology specialties, all of which will be profoundly affected if the MHRA's interpretation of the Directive is upheld. It must be appreciated that, as well as affecting a large number of specialist and reference laboratories, many NHS laboratories perform in house assays on samples provided by other trusts. The costs involved in complying with the IVDD, if the present MHRA interpretation is upheld, will divert funds away from other healthcare initiatives and will inevitably stifle further development of specialist in house assays which make an immense contribution to our health services. The principles of the Directive are sound and its introduction will have a beneficial affect on pathology due to better regulation of IVDs, which are placed on the market. However, applying the Directive to in house assays can only be detrimental to the efficacy of pathology services across the UK and therefore have a negative affect on the health of the nation.
Sharp
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Evaluation and Standards Laboratory, CPHL, 61 Colindale Avenue, London NW9 5DE.
D005062:European Union; D006801:Humans; D007753:Laboratories / Q000331:legislation & jurisprudence / Q000592:standards; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D013222:State Medicine; D006113:United Kingdom
D011933:Reagent Kits, Diagnostic