Small firms left vulnerable in wake of UK "home-brew" ruling
This article was originally published in Clinica
Executive Summary
Clinical laboratories in the UK are reeling from shock following the open publication by the Medicines and Healthcare Products Regulatory Agency of two letters dictating the need to CE mark some IVDs that are made in-house that put at risk thousands of "home-brew" IVDs. It seems that most laboratories were totally unaware until they read the MHRA's statements of the fact that the IVD Directive applied to them and are now rushing to establish where they stand and what rules they need to comply with.