CL-2022-000676 - [2025] EWHC 2486 (Comm)

Ironically, ultimately the gowns were manufactured by the WTT factory. The Kunshan Jiehong factory (which had submitted full proof of valid CE marking) was not used.

The gowns were sterilised by a terminal (i.e. post-manufacture) process of electron beam irradiation. This is a process in which high energy electrons are used to bombard the product to be sterilised, by scanning in a sweeping motion. It was carried out by seven other factories: CGN Dasheng, Shanghai Eagle High Technology Co. Ltd, Wuxi Futeng, Zhejiang Hanqing Biotechnology Co. Ltd, Nanjing Xi Yue Technology Co. Ltd, Shanghai Shuneng Irradiation Technology Co. Ltd and Sterigenics Shanghai E-Beam Co. Ltd. Of those seven sterilisation facilities, Wuxi Futeng had been notified to the PPE Cell’s Technical team in the course of the procurement exercise.

DHSC arranged for the collection of the Gowns from the sterilisation plants in China between approximately 12 July 2020 and 3 September 2020, on an Incoterms “ex works” basis. The Gowns were supplied in cardboard boxes of 90 gowns. Each box gave the WTT origin and a lot number as well as a generic CE mark (with no notified body number). The boxes also stated “Sterile Surgical Gown. Sterilized. Sterile R” and gave the contract number and Medpro’s details. Within the boxes each Gown was in a sealed plastic bag. Inside the bag was a label stating “Sterile Surgical Gown” as well as Medpro’s logo, sizing details and details of the EN 13795 requirements. AT the bottom of each label was the notation “CE …. Sterilized. Sterile R”. Both from the boxes and from the presentation of the individual gowns it was therefore clear that the Gowns claimed to be sterile; and that they did not have the conventional CE marking including a notified body number.

The gowns were loaded by Medpro’s agents into shipping containers, and the containers were then sealed and taken to port for shipment to the UK. Medpro made the arrangements with Uniserve, which provided logistics services to DHSC during the Covid-19 pandemic. The Uniserve contract contained a number of express obligations on Uniserve which indicate that Uniserve was to carry out inspections and perform quality control and other checks on the gowns collected from the sterilisation plant. That was to be done either at the gates of the sterilisation plants or at the freight stations in port. There was however a degree of doubt about whether Uniserve ever did conduct inspections on behalf of DHSC.

There were then 21 voyages with shipments of gowns departing China between 21 July 2020 and 13 September and arriving in the UK between 20 August and 23 October 2020.

UK-side storage and logistics were managed on DHSC’s behalf by specialist companies. The gowns were moved to storage sites in shipping containers and were then unloaded and palletised for storage in warehouses, or kept in shipping containers at warehouse or container park sites.

Supply Chain Coordination Limited (“SCCL”) managed the NHS’s supply chain and the storage of goods bought during the pandemic. It compiled a “Freight Records Spreadsheet”, which shows the various voyages of gowns by reference to individual containers and their storage location as at July 2023. A simplified version, which has been grouped by voyage in chronological order, shows that, upon arrival in the UK, gowns were either unloaded into warehouses or into shipping containers (and sometimes unloaded into warehouses on a later date). To minimise costs, shipping line containers were generally destuffed and the goods loaded into other containers. This might have happened near the port of arrival or at the warehouse site.

SCCL has also produced a “Storage Costs Spreadsheet”. The data was obtained from frontline organisations involved in managing the stock and put together by SCCL’s data analysis team. It shows (at a high level) where the gowns were between 15 February 2021 and May 2024. DHSC argues that this demonstrates that they were stored in warehouses or containers during that time and is also relied on in support of DHSC’s storage costs claim. It is considered further below in this context.

On 11 September 2020, a Ms Zarah Naeem conducted a MHRA Checklist clearing Daventry Stock in respect of the WTT Gowns. The evidence, including Ms Breslin’s cross-examination of Ms Naeem, indicated that there was no inspection before this date. The Checklist was detailed and was very specific as to the requirements of the regulations, including notified body number for sterile gowns. She completed the checklist via a review of photos of some of the stock and any documents submitted with them. As to the latter, there was apparently an Internet report, because Ms Naeem emailed Charlotte Murphy stating: “Please can you confirm/verify this Intertet report is genuine.It is related to a large gown order for the NHS”. In completing the checklist on the gowns, she recorded that there was a “CE mark but no CE NB number”.

On 19 October 2020, Intertek sent an email to NHS Tech Assurance (following the distinct query as to the report’s provenance) stating, in relation to the testing report in relation to Medpro’s Gowns: “The report is not issued by us.”

These two anomalies having been noticed, Ms Naeem sent the submission on to Clipper (a UK-side logistics company providing services to DHSC and specifically providing the material for assessments) for review.

On 22 October 2020, Clipper contacted Mr Page asking inter alia for declarations of conformity to the MDR, an Annex V a certificate for sterility and an explanation of why there was “no NB number next to CE mark… (indicating sterility)” as well as a QMS certificate.

Separately, around 28 October 2020, the PPE Cell found during a technical assessment of a further proposal to supply gowns by Medpro that it had provided an inauthentic report from a testing company called Intertek. That day, Dr Darren Mann wrote to the MHRA stating:

“Following our technical assessment of a proposal for a surgical gown to be supplied by PPE Medpro (manufactured by Wuijang [sic] Tutaike Textile & Finishing co. Ltd) we have found that the test report provided is inauthentic. Please see email indicating that the test certificate provided was not issued by Intertek.

Please note that you are currently reviewing surgical gown products already supplied by the supplier: SKU GCIS0113 and GCIS0114 Medpro currently locked at Daventry (please see earlier correspondence referring).

Internal Tech Assurance protocols provide for inauthentic documents and certificates to be referred to Anti- Fraud Office and the relevant Regulator for awareness and action.

We wish to ensure that other healthcare product procurers are made aware of the presence of these inauthentic documents and for caution to be emphasised.

Grateful if MHRA could manage this information according to your procedures and to engage with Medpro accordingly.”

Nicole Small of the MHRA then emailed Devices Compliance at the MHRA, with Ms Naeem in CC, stating the following, after which a referral incident was created at the MHRA:

“Issue:

(1)

Fake report – PPE/MD certificate to a product standard BS EN 13795 (SHAT doc Intertek)

(2)

Non-conformity – CE mark on label but no Notified Body number against it for a sterile product. No assurance/evidence that sterility aspects (Annex V or equivalent) has been achieved in order to place CE mark on this ‘sterile’ device. DSSG will pursue this subject to resolution of the fake report from Intertek

Stock locked in Daventry currently …

MHRA will not approve this to stock [sic] to be released unless point 1 has been resolved”

On 29 October, Ms Small updated Devices Compliance, again copying in Ms Naeem, stating:

“Update:

The Intertek fake report (to BS EN 13795 SHAT 06648491) was sent to DHSC team by Medpro to provide evidence for potential future procurement.

As mentioned in our call, MHRA also hold a different test report to BS EN 13795 SHAT 06497575 which was provided within a procurement system called OneWorld relating to Daventry stock already supplied by Medpro. Verification of this report has not been established yet.

So we hold two reports – one fake – one TBD for the same gowns from the supplier Medpro.

The label says sterile product but CE mark does not hold Notified Body number against it to demonstrate conformity assessment to Annex V or alternative has been carried out by NB. DSSG has asked for this certificate.

Please can you investigate liaising with DSSG as appropriate.

The stock in UK will not be released into the supply chain until resolved.”

This prompted the MHRA to raise both matters as issues in relation to Medpro and to refuse to release the stock unless the issues were resolved.

On 4 November, Alan Taylor, Senior Devices Inspector at MHRA, sent a letter to Medpro, enquiring as to why the Gowns had been supplied in packaging bearing a CE mark with no notified body number, and requesting a certified copy of the EC certification issued by an appropriate notified body that related to the gowns to give assurance that they were sterile as claimed.

On 6 November, Mr Page emailed Mr Taylor setting out Medpro’s position on the Gowns’ compliance with the Contract. He referred to the Contract and, with reference to section 6 of the Order Form, explained that “[t]he deliverables table clearly omits the "CE #." This is because TTK's sterile surgical gown did not have the requisite Notify Body accreditations, and we made no representations that it did. [Compare the Mask Contract which includes requirement for CE mark]”. He also referred to section 7 of the Order form which “clearly omits the CE certification as a specification”. Mr Page went on to add that: “The Gown Contract omits any requirement for CE marking and affixing of NB numbers for the reasons stated above. This is of particular relevance to the TTK manufactured gowns (the JHSTG [i.e. the Kunshan Jiehong factory] manufactured gowns are CE marked with NB number and the technical and packing documentation supports this)”. [There were, in fact, no gowns manufactured by the Kunshan Jiehong factory.]

On 17 November, Mr Taylor responded to Mr Page’s initial position. Mr Taylor explained that the Gowns had been CE marked and labelled as “Sterile R”, despite there being no notified body certification or relevant conformity assessment. Mr Taylor states that he understands that Mr Page himself also does not believe that the stock has a notified body certification. He goes on to state that “The CE mark should only be affixed once all relevant requirements of the Medical Device Directive 93/42/EEC have been applied. This includes completing the relevant conformity assessment (e.g. Annex V) for sterility aspects of Class I medical device. If the requirements of the Regulations have not been met in full, the CE mark of the gowns should not be affixed to the label”. Mr Taylor stated that “On this basis I will advise that the stock at Daventry cannot be released to the NHS until this matter is resolved satisfactorily and the product has the correct notified body certification”. Mr Page responded to the email of Mr Taylor, indicating that he was keen to resolve the issue and proposing a call, which took place the following day. He chased Mr Taylor again on 18 November. Mr Taylor then asked for questions to be shared in advance, noting he was not going to be able to engage in the contractual matters raised by Mr Page.

After Mr Page chased Mr Taylor for an update on the process on 23 November, Mr Taylor responded on that day stating: “I think we agreed that you would talk with the manufacturer or EU representative and ask them to provide suggested corrective action regarding the labelling of any further relevant products”.

Also on 23 November, Mr Page emailed Mr Taylor in relation to the Intertek report which was flagged as not being genuine, stating:

“It has come to our attention that a marked up copy of an Intertek report SHAT06648491 dated 28^th September 2020 was incorrectly submitted to the DHSC in connection with a procurement exercise for Impervious Gown…

Although the procurement exercise did not proceed and no BMPC8 gowns have been supplied, whether in the UK or elsewhere, in accordance with best practice we wish to bring this error to your attention immediately, and recall the copy of SHAT06648491 report dated 28^th September 2020. We have the original certified Intertek report and attach a copy for your records.”

On 24 November, Mr Page responded to an email from Mr Taylor in which he had raised various questions. As regards the labelling of the gowns, Mr Page stated:

“As you have made clear, goods do not meet the regulations required to affix the CE mark, we have already given you an explanation as to why these goods were offered, ordered and delivered. Is there a regulatory path to resolve this? Or are there other paths to deal with this, such as a relabelling exercise or derogation.” Mr Page also went on to say: “We confirm that the goods do not have a NB number. Having already talked through the history of the product and how we came to supply this to the DHSC, if an NB number cannot be applied, can the goods be relabelled and re-purposed as non-sterile gowns [subject to approval and instruction from our client the DHSC]. Or does the MHRA have any other solutions that we can consider and action?” As regards derogation, Mr Page stated “Derogation was mentioned to us in correspondence with the DHSC procurement & technical assurance team prior to contract award. It was then our understanding that they would have worked to obtain this status. If this has not been done by the relevant teams, can we work with you and your team to have this done on our clients [sic] behalf?”

Responding on 30 November, Mr Taylor stated that: “The only method to bring this product into compliance is for it to have supporting notified body certification”. He also went on to say: “I appreciate all the information and suggestions you have provided me with but the gowns at Daventry will not be considered compliant by the MHRA until they have notified body certification”.

Between 30 November 2020 and 22 December 2020, there was further contact between Mr Page and the MHRA, and between Mr Page and DHSC, but no progress was made.