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

Fecha: 01-Oct-2025

The Essential Technical Requirements Document (“ETRD”)

50.

On 23 May 2020, the Government published a document setting out “Essential technical requirements for gowns, gloves, masks, respirators, eye protection and coveralls where no CE mark has been obtained or where an alternative use is proposed of an existing CE marked product”. The document was prepared by the MHRA and the HSE, fairly obviously in the light of the Recommendation.It is relied on by Medpro as highly relevant to contractual construction.

51.

The ETRD set out the approach that the MHRA intended to take following the Commission Recommendation. It pointed out that:

“Normally, such products must meet requirements set out in the relevant legislation as listed above and hold a valid CE mark before being placed on the market or put into service. However, bearing in mind the health and safety is the upmost priority, it is of paramount importance to ensure that the most appropriate PPE and medical devices ensuring adequate protection are swiftly made available to those who need it most during the Covid-19 threat.”

“Where market surveillance authorities find that PPE (Health and Safety Executive HSE) or medical devices (Medicines and Healthcare products Regulatory Agency MHRA) ensure an adequate level of health and safety in accordance with the essential requirements laid down in Regulation (EU) 2016/425 or the requirements of Directive 93/42/EEC even though the conformity assessment procedures, including the affixing of CE marking, have not been fully finalised according to the harmonised rules they may authorise the making available of these products for supply to frontline healthcare if sourced by Government and with the caveat that they are not distributed more widely. MHRA call this exemption from devices regulation a derogation.”

52.

It then explained key criteria thus:

“Before such COVID-19 related products are purchased by or donated to the Government/NHS to be used by NHS healthcare workers, it must meet all the following criteria to ensure they are fit for the purpose intended, will work in line with stated performance and have been assessed as such.
The products are therefore designed and manufactured in accordance with either:
a)
a relevant harmonised European standard, or
b)
any of the standards referred to in the WHO guidelines or,
c)
any other non-EU standard or technical solution, provided that the specific solution ensures that the product complies with the applicable essential health and safety requirements”

53.

Its purpose was then set out: “This guidance sets out the essential technical and labelling requirements for these products to support meeting the criteria specified above.” It, however, stated that “Meeting these requirements does not guarantee clearance of an application by MHRA or HSE, as relevant. Robust scrutiny by MHRA or HSE of the information in your application will take place before a decision is made to allow you to supply to the UK.”

54.

Table 1 of the ETRD then set out the “essential requirements” for medical devices, where “must” defined essential requirements and “should” defined requirements which were highly desirable but where consideration could be given to omitting the requirement to speed up provision. It listed a number of items - surgical face masks, gloves, and the like.

55.

Under “sterile gowns” the table included the requirement:

“Must be validated as sterile with Sterility Assurance Level (SAL) of 10^-6”

The parties are in agreement that this was a requirement of the supply of gowns in question here.

56.

More controversial was the final column (headed “relevant standards for design and performance”) which stated:

“BS EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods
or
AAMI PB70 (all levels accepted or equivalent)
and BS EN 556-1:2001 for terminally sterilised medical devices (where applicable) or equivalent technical solutions”

AAMI PB 70 is the approximate US equivalent of ES 13795. As will be apparent from the preceding section this notation indicated a requirement for compliance with a construction/performance standard and a sterility requirement.