Richard James, a Cabinet Office official who worked in the DHSC’s Covid-era “PPE Cell”, was first to give evidence. He confirmed that he had emailed PPE Medpro in June 2020 to say that its sterile surgical gowns had been “approved by Technical”, referring to the government’s internal Technical Assurance team . This approval was a key turning point that allowed the controversial supplier’s £122 million order to progress.
But under questioning, James admitted that PPE Medpro had never supplied the certification required under EN 556-1 — the European standard for terminally sterilised medical devices — nor a CE mark with an accompanying Notified Body (NB) number, which is generally required under medical device regulations .
When challenged on this, James said the approvals were granted on the basis of a “capability to meet the technical standards” and not necessarily full compliance at the time. The documents provided by PPE Medpro were uploaded to the government’s Mendix platform, and the Technical Assurance team assessed their adequacy remotely, without physical access to the products, which were being manufactured in China during the pandemic’s global supply chain chaos .
Repeated references were made to the Essential Technical Requirements Document (ETRD), which allowed for “equivalent technical solutions” during the pandemic if a product could not meet usual standards. PPE Medpro later argued in submissions that it was operating under this clause, although James’s emails suggest he continued to request EN 556-1 compliance until the very end .
The court then heard from William Clarke, a senior member of the Technical Assurance team, whose role was to review the sterilisation credentials of PPE Medpro’s offer. Clarke admitted under questioning that he had mistakenly approved the submission without spotting the absence of a Notified Body number next to the CE mark — a key requirement for Class I sterile medical devices .
“I should have spotted it,” Clarke told the court, accepting that his review was flawed and conceding that PPE Medpro’s submission “did not evidence the requirements in the ETS [Essential Technical Specification]” as claimed in his signed witness statement .
Pressed further, Clarke acknowledged that PPE Medpro never supplied certification showing conformity with EN 556-1 and admitted he had relied in part on a Certificate of Free Sale issued by the MHRA, the UK’s medicines regulator. Yet, remarkably, he also said he “didn’t know what a Certificate of Free Sale was” at the time and still couldn’t explain its significance beyond it being “valid-looking” .
The hearings laid bare how decisions about contracts worth hundreds of millions were based on fast-moving exchanges of emails, assumptions about technical standards, and documentation that was often incomplete or misunderstood.
At one point, Clarke told the court he believed a sterilisation certificate for ISO 11137 (a radiation sterilisation standard) sufficed for EN 556-1. But when questioned, he admitted ISO 11137 does not include the sterility assurance level (SAL) of 10⁻⁶ required under EN 556-1. “Not at all,” Clarke eventually agreed .
Meanwhile, PPE Medpro’s representative, Anthony Page, had repeatedly shown signs of confusion in emails, misreading the specification and wrongly thinking the standards were either EN 13795 or EN 556, rather than both. James and Clarke both confirmed that this misunderstanding persisted throughout their exchanges .
The courtroom exchanges painted a picture of a procurement system overwhelmed by urgency, dependent on rapid decisions and stretched resources. James admitted he often gave guidance to suppliers like PPE Medpro based on conversations with technical colleagues, rather than his own expertise.
Although DHSC’s case rests in part on claims of invalid CE marking and lack of sterility, both witnesses for the department conceded that PPE Medpro’s documentation never included proof of compliance with the relevant EN 556-1 standard, and yet approval was still granted.
Clarke’s testimony appeared to support PPE Medpro’s wider defence — that it acted in good faith and was allowed to proceed because DHSC officials signed off on its documentation. However, his candid admission that he made a “mistake” approving the submission could prove pivotal as the trial unfolds.
The hearing continues on Monday.
