Meeting the technical requirements/ No requirement to have a CE mark with an NB number
Meeting the technical requirements/ No requirement to have a CE mark with an NB number
This is where the case engages most clearly with the exchanges. Medpro relies on the “gowns approved by technical” statement, against the background of the process of submission, as a clear and unequivocal representation. But even so and taken against the background, this falls some way short of the unequivocal or clear representation or basis for assumption which would be needed. The statement does not itself say what is relied on or mention CE marking. And any representation has to be placed against the wider background (including as to sterility), the structure of the process and Medpro’s knowledge of the process (i.e.) that the contracts stage needed still to be completed). On this basis at best this statement can be taken as an implicit representation that the DHSC considered that the material suggested that the gowns were capable of meeting technical requirements. Such a requirement is itself so vague that it could not found any estoppel.
Further, to the extent anything could translate into a representation/assumption, there is nothing which could make a clear representation/assumption about CE marking. Medpro’s case was that:
It is common ground that Medpro never provided and never purported to provide a valid CE mark with a NB number for the sterile gowns manufactured by WTT.;
Mr Page’s email sending the ISO certificate was preceded by an email stating “We are certain that we are 100% compliant” and was accompanied by the comment “Hopefully this is all your technical department requires”;
The response was an approval by Technical and Mr James’s confirmation that “Gowns have been approved by Technical!”
This is said to be the basis for a clear and unequivocal representation that there was no requirement to have a CE mark with an NB number. As Mr Samek KC put it in closing: “it is obvious what is implicit in that, that DHSC were satisfied with everything that we had given them and that's why we passed on to the next stage and they sign the contract. No valid CE mark was therefore required. No need to demonstrate anything else.”
That expansive statement of what is sought to be read into the terse one liner needs only to be stated to be seen to be wrong. Nor can it be said that one can get to an unequivocal representation/assumption via an argument that: Medpro was “100% compliant”/ therefore Medpro had provided everything that DHSC required/ therefore no need for an NB number. The short point is that the absence of an NB number in the photo was at least equally consistent with the photo showing a blank pro forma, which would have the producer’s own NB number applied. There is simply not enough explicitness or enough absence of alternative meanings for a clear representation/assumption to be the result.
- Heading
- This judgment was handed down by the court in person and by circulation to the parties’ representatives by email and released to The National Archives. The date and time for hand-down is deemed to be
- Sterility 101: An Introduction to sterility and Medical Device Law
- ISO 11137: Requirements of a Sterilisation Process
- Sterility level: EN 556
- Medical devices: MD Directive and MDR 2002
- Other relevant standards
- Summary
- Factual Background
- The PPE Cell
- The Recommendation
- The Essential Technical Requirements Document (“ETRD”)
- Precontractual Negotiations
- Closing
- Final Approval and Contract
- Manufacturing, delivery and inspection
- Rejection of the Gowns
- Testing of Gowns
- The Trial and issues
- The Contractual Claim
- The parties’ cases on construction
- The significance of the accepted obligation to deliver gowns with an SAL of 10 -6
- Was there breach of a requirement for a formally validated process in this case?
- Did the Contract require EN 556 or an Equivalent Technical Solution?
- Did the Contract require CE marking?
- The original case: Statistics, Physical Testing and Sterility
- Estoppel and related concepts
- Representation/assumption: clear?
- Approval of an ETS in place of EN 556
- Meeting the technical requirements/ No requirement to have a CE mark with an NB number
- Reliance
- Estoppel and validated process/SAL
- Non-Reliance and Entire Understanding Clauses
- Remedies
- Was the right to reject lost?
- Damages: The value of the Gowns and Mitigation
- Damages: The Claim for Storage Costs and Gown Disposal
- The Counterclaim
- Common mistake and rectification
- Negligent misstatement
- Conclusion
- Annex 1: Statistics, Physical testing and Sterility
- The testing
- Statistics
- The evidence and its implications
- The evidence gap
- Conclusion
- Annex 2: Relevant provisions of the Contract The Contract between DHSC and Medpro consists of a front page and several documents
- Order Form Section 5 of the Order Form “ The Supplier shall supply the deliverable described below on the terms set out in this Order Form and the Schedules and Annex A. Unless the Contract otherwise requires, c
- Section 7 of the Order Form is headed “Specification” and states: “The specification of the Deliverables is as set out in Annex A.1 – A.9 [26.06.2020]. Not as embedded/attached documents. Please confi
- Schedule 1
- Clause 2.2 of Schedule 1 states that the Order Form is to “ include, without limitation, the Authority’s requirements in the form of its specification and other statements and requirements, the Suppli
- Clause 3 of Schedule 1 is headed “ Quality assurance standards ” and states: “The following quality assurance standards shall apply, as appropriate, to the manufacture, supply, and/or installation of
- Conclusions
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