The ongoing High Court case between PPE Medpro and the Department of Health and Social Care (DHSC) has unveiled serious flaws in the emergency procurement of PPE. Key testimonies from civil servants exposed the lack of compliance with essential medical device regulations, particularly concerning equipment certification. The approvals granted were based on a perceived capability to meet standards, not on actual compliance, raising questions about the validity of the procurement processes. Central to the discussion were the flexible standards invoked during the pandemic, which may have compromised product safety and efficacy.
Richard James confirmed that he emailed PPE Medpro in June 2020 to say that its sterile surgical gowns had been "approved by Technical".
James admitted that PPE Medpro never supplied the required EN 556-1 certification, nor a CE mark with an accompanying Notified Body number.
Documents were uploaded to the government's Mendix platform for assessment by the Technical Assurance team without checking the physical products.
PPE Medpro argued it operated under the Essential Technical Requirements Document which allowed for "equivalent technical solutions" during the pandemic.
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