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

Fecha: 01-Oct-2025

Did the Contract require CE marking?

Did the Contract require CE marking?

225.

In the premises, this point is not determinative. For completeness however, so far as this is concerned there is a tension between the parts of the Contract on which DHSC relies and the passages which Medpro emphasise.

226.

Medpro are right to say that:

The Order Form took precedence in the event of any conflict with other provisions in the Contract;

Section 6 of the Order Form left the box titled “CE#” blank. That is certainly consistent with a case that the gowns would not have and therefore did not need a “CE#”;

Section 7 of the Order Form is also consistent with that. It provided that “specification of the Deliverables” was as set out in the Annex and the photographs within the Annexes did not include an NB number and Medpro never provided a picture of a valid CE mark (or any valid CE mark number for the WTT supply).

227.

However to some extent that case as advanced was at odds with its own pleaded position. The emphasis on the photos was not consistent with its earlier view that the photographs in the Annex did not form part of the Contract, and the parties had “not in fact reached any agreement as to what the ‘Packaging specification’ should be” and “were at most intended to illustrate only that the said gowns would be wrapped and boxed in a way which was sufficient to permit the irradiation of the said gowns and maintain their sterility (subject to proper transportation and storage of the same by the Claimant and/or its servants or agents)”.

228.

Ultimately the sheer weight of provisions within the Contract which required compliance with the applicable laws (and the consequent extent of “reading down” called for) would in my judgment outweigh (i) the indications to be gleaned from the failure to specify CE marking on the Order Form (which are not clear, but ambivalent), and (ii) the obviously in some respects inaccurate photos (the WTT photos indicated show a product that was intended to be sterilised by ethylene oxide rather than by irradiation). All of the following provisions point to a requirement for CE marking:

Schedule 1, clause 12.2 (obligation to comply with the Medical Device Regulations);

Schedule 2, clause 1.1.6 (obligation to supply the goods “in accordance with the Law”);

Schedule 2, clause 7.1.9 (obligation to “comply with all Law”);

Schedule 2, clause 7.2 (obligation to comply with “Law and Guidance” relating to medical devices, and warranting that the medical devices would have valid CE marking or Product Authorisation);

229.

Furthermore Regulation 10 of the MDR 2002 is clear and explicit as to the need for a CE number. There was no discussion between the parties as to use or otherwise of a CE number – and the WTT pictures did show a CE mark, just not one which was apt for sterile products. The use of the “non-sterile” CE marking would be a breach of the law, and it would be nonsensical for the parties explicitly to contract for that outcome.

230.

Accordingly to the extent necessary I would conclude that on this point DHSC also had the better of the argument, and CE marking was required.