01/25/2022 | Press release | Distributed by Public on 01/25/2022 11:27
The documents attached define the technical and regulatory standards for PPE.
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Request an accessible format.These documents are for new suppliers and manufacturers when they are using the tendering process for the supply or manufacture of PPE.
The guidance is intended to ensure that these parties understand our regulatory requirements and that all products must comply with the stated standards, legislation and/or directives.
It includes advice for health and social care providers on the essential technical requirements and how these impact any existing PPE stocks, direct supply, donation or purchasing which they may now also be conducting or receiving outside of the national procurement model for PPE.
The following 3 pieces of guidance have been deleted as they are out of date:
The guidance was intended for new and novel manufacturers to understand relevant performance requirements of medical devices and PPE, where they were intended to be supplied to healthcare for protection against the coronavirus disease and where the item had not undergone full conformity assessment.
This guidance has been withdrawn because regulatory easements are no longer available for PPE.
Any new PPE must satisfy the essential health and safety requirements of the 2016/425 PPE regulations and carry the CE or UKCA mark.
Medical devices must conform to UK MDR 2002 or EU MDR to use the UKCA or CE mark. For exceptional use cases please read MHRA guidance on exemptions from the Medical Device Regulations during the coronavirus outbreak.
In 'Transparent face mask technical specification', updated the visibility requirements so that anti-fogging coatings are not removed during testing.
Deleted 'Essential technical requirements for new high-volume manufacture of personal protective equipment (PPE) and medical devices (MD) during COVID-19', 'Essential technical requirements for PPE and medical devices: further information for manufacturers and suppliers' and 'Essential technical requirements for PPE and medical devices: further information for health and social care providers' as they out of date.
Updated section 5.10 of the Transparent face mask technical specification.
Added new attachment: 'Transparent face mask technical specification'.
Added the following 3 attachments:'Essential technical requirements for new high-volume manufacture of personal protective equipment (PPE) and medical devices (MD) during COVID-19', 'Essential technical requirements for PPE and medical devices: further information for manufacturers and suppliers' and 'Essential technical requirements for PPE and medical devices: further information for health and social care providers'. These replaced 2 existing guidance documents, 2 technical specification documents and 4 apron documents.
Accessible documents uploaded.
Version 3 of Essential Technical Specifications replacing version 2.
We have attached new documentation and amended the details section to reflect.
Additional attachments added
Removed attachments
Additional upload of documentation.
First published.
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