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

On 23 December 2020, DHSC rejected the Gowns by the Rejection Notice:

“Faults with the Goods

3.

Under the Contract Medpro is required to supply Goods to DHSC for use in the NHS in accordance with:

a.

BS EN 13795:2019 (clause 3 of Schedule 1 of the Contract); and

b.

The relevant requirements of applicable laws and regulations applicable to the supply of PPE, including, as applicable, the EU PPE Regulation 2016/425, the Personal Protective Equipment (Enforcement) Regulations 2018 and the Medical Device Regulations 2002 ("the PPE Laws") (Clause 12.2 of Schedule I of the Contract).

4.

Further, the Contract requires Medpro to ensure:

a.

The appropriate conformity assessment procedures(s) applicable to the PPE Goods have been followed:

b.

All declarations of conformity and approvals required by PPE Laws are in place prior to delivery of any PPE Goods to the Authority;

c.

Where required by PPE Laws, there is a CE Mark affixed to the PPE Goods in accordance with the PPE Laws; and

d.

Where necessary current EC-type examination certificates are in place for the PPE Goods.

Further, Medpro is required to use reasonable skill and care in the manufacture of the PPE Goods (Schedule 2 clause 7.1.3) and supply PPE Goods which are of satisfactory quality and fit for their intended purpose (as warranted at Schedule 2 paragraph 7.1.1).

6.

In breach of the Contract, Medpro has delivered Goods which, amongst other things, are not compliant with the PPE Laws and/ or Medpro has not ensured compliance with the requirements set out in the Contract and summarised at 4(a) to (d) below, and/ or the Goods are not fit for their intended purpose, namely use as sterile surgical gowns in the NHS.

7.

As you are aware, the Goods have not been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for use as sterile surgical gowns in the UK. We understand that MHRA have written to Medpro direct setting out the reasons why the Goods are non-compliant with the PPE Laws so far as they relate to medical devices. I refer you to MHRA's correspondence for full details in this respect, but in summary, Medpro has failed to provide the essential certification MHRA requires to establish that the Goods have been reliably sterilised for medical use. In the absence of a satisfactory response from you the Goods have been found by MHRA to be non-compliant with the PPE Laws (relating to medical devices), with improperly affixed CE Marking, and unlawful if distributed in the UK.

8.

As a consequence of the breach of Contract, DHSC cannot use the Goods in the NHS.

Rejection of the Goods

9.

In light of the above breach of Contract, DHSC rejects all the Goods purchased under the Contract in accordance with Schedule 2 clause 4.2 and/or 4.6 of the Contract (Rejected Goods)”.

On 11 February 2022 DHSC sent a letter before action to Medpro, outlining its claims on the basis that Medpro did not have the relevant CE accreditation or a derogation, as a result of which the gowns could not be used.