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

Fecha: 01-Oct-2025

Approval of an ETS in place of EN 556

241.

Medpro’s case was stated in its written opening, that DHSC expressly (alternatively impliedly) represented that this was the case by Mr James’s email confirming approval and this was also conduct that crossed the line for the purposes of estoppel by convention, creating or confirming the parties’ common assumption (objectively construed) that the equivalent technical solution was approved.

242.

Medpro indicated that the representation/assumption arose from the following:

DHSC had specifically requested that Medpro provide certification in relation to EN 556-1, which was never provided;

The gowns were then approved by Technical. The approval by Technical therefore cannot have been on the basis of the EN 556-1 solution. It follows that, objectively construed, approval must have been on the basis of an equivalent technical solution;

When first asked for the EN 556-1 certificate, (in addition to seeking clarification as to the certification requirements) Mr Page asked for the ISO number which was equivalent;

As the final certificate provided by Mr Page certified compliance with ISO, it was logically this “equivalent” standard that was approved;

It was obvious to both parties that the existing documentation did not include any EN 556-1 certification. In those circumstances, when Mr James asked where the SAL was confirmed he must have been asking whether the SAL could be confirmed by an alternative document – i.e., an equivalent technical solution;

Thus, Technical’s approval was on the basis of an equivalent technical solution. Moreover, this representation was confirmed and repeated in Mr Graham’s passing on to Mr Page the fact that Technical had approved the Medpro submission.

243.

I do not accept that any such clear or unambiguous representation or assumption can be spelled out of this material, taken against the full context. There was an exchange where Mr Page was obviously wrong in saying that what was needed was EN 13795 or EN 556 and that Medpro was fine because their supplier could do EN 13795. Mr James clarified – and gave a contextual explanation that what was needed was something which showed the ability to comply with the SAL (which EN 13795 did not). To this Mr Page replied with the ISO 11137:1 certificate – which demonstrated compliance with some parts of a quality assurance system capable of producing sterile goods. Things were happening at some speed and not everything was spelled out. After this DHSC indicated that “gowns approved by technical”. After that the full Contract terms were sent, some days in advance of agreement.

244.

Was there an unequivocal representation that EN 556 was not needed because an ETS was agreed? While it may be the case that Mr Page (who appears not to have been very familiar with the relevant standards) may, subjectively, have believed that he was being told that what he had provided was enough to satisfy compliance with the requirements, if he did so (and of course there was no evidence from him that he did so understand the exchanges) he did not do so because there was objectively any clear statement or basis for assuming that (i) the ETS process was engaged (ii) that a derogation had been sought or (iii) that an ETS had been approved. There was no mention of an ETS in any of the relevant communications. Nor was there a clear representation that EN 556 was not required.

245.

The ETS route had been suggested (as an undesirable route) earlier on in the discussions. In another contract it had been positively engaged with and specifically discussed. Here there were no explicit indicators of following this route. Further the immediate backdrop to the “Gowns approved by Technical” was a series of exchanges about whether the material provided grappled with the question of SAL; and Medpro was not saying “yes, but by another route”. Medpro was repeatedly assuring DHSC that they were certain they could comply with the requirements provided to them: “we always deliver 100% quality and on time”. If anything objectively Medpro was asserting compliance.

246.

It is worthy of note that Medpro have never been entirely clear about what the ETS agreed was: was it 11137:1? Or was it “what the Annex says”? Nor could Medpro ever address how either of these were equivalent. The only possible way an equivalent technical solution could come into the picture was via the reference to ISO 11137; but objectively in the discussions Medpro appeared to rely on this as evidence of compliance with EN 556. Further if equivalence were objectively being asserted it would need to be a functional equivalence, which this was not. If Medpro properly understood the nature of sterility and the requirements of sterile gowns it would have appreciated that all it had supplied went to manufacturing standards, not to the question of sterility at all. ISO 11137 is not about how to designate a medical device as “sterile”. That is what BS EN 556 is for. ISO 11137 is about the requirements to develop, validate and routine control a radiation sterilisation process. In terms of process, it comes, logically, before BS EN 556—not instead of. Indeed, ISO 11137 also refers to BS EN 556 at various times, further demonstrating that BS EN 556 is very much not the same as ISO 11137, e.g.: “Attention is drawn to regional and national requirements for designating medical devices as ‘sterile’. See, for example, EN 556-1 or ANSI/AAMI ST67”. In that context there was no equivalence and no-one understanding the area could have understood a representation in that sense.