© Crown copyright 2021
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: email@example.com.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/technical-specifications-for-personal-protective-equipment-ppe/essential-technical-requirements-for-ppe-medical-devices-further-information-for-health-and-social-care-providers
1. Who developed the essential technical requirements
The essential technical requirements for PPE/medical devices have been developed by the Health and Safety Executive (HSE) and the Medicines and Healthcare Products Regulatory Agency (MHRA) on behalf of the NHS in the UK to facilitate the rapid production of critical PPE/medical devices for UK health and social care workers.
2. Types of PPE/medical devices covered by the requirements
The essential technical requirements are focused on priority areas of PPE/medical devices, specifically gowns (isolation and surgical), gloves, masks, respirators, eye protection and coveralls.
The essential technical requirements are intended for circumstances where either the manufacturer has not had sufficient time to fully comply with the regulations and obtain the CE mark, or where an alternative use is proposed of an existing CE marked product.
3. Reasons for developing these requirements
The government is committed to facilitating the rapid production of PPE/medical devices within the UK to ensure health and social care workers across the system have the critical equipment they require, in the right quantity and at the right time, including in light of limitations on international production and imports.
Normally, such products must meet requirements set out in the relevant legislation and hold a valid CE mark before being placed on the market or put into service. These requirements set out the essential technical and labelling requirements for PPE and medical devices where the conformity assessment procedures, including the affixing of CE marking, have not been fully finalised.
This approach will enable the rapid production of such products, without some of the legal requirements normally required, but without compromising on the health and safety standards required to ensure adequate protection to those who need it most during the coronavirus (COVID-19) threat.
In addition to importing PPE/medical devices where available, the government is working with UK industry to enable UK-based manufacture and supply of critical PPE/medical devices. Whilst the portal for UK manufacturers to register their interest has now closed, there will be regionally-led tendering initiatives working with manufacturers to ensure the essential technical requirements can be met.
Eventually, for continuing supply, PPE/medical devices will need to be CE marked and fully compliant with the PPE and medical devices regulations where applicable.
4. Comparing the essential technical requirements to normal standards
Both the PPE Regulations 2016/425 and MDR 2002 lay down essential requirements on health, safety and performance of the products they cover. However, both legal frameworks are technologically neutral and do not prescribe any specific mandatory technical solutions for the design of the products. Therefore, a number of technical solutions may be used by manufacturers to meet these essential requirements.
The published essential technical requirements for healthcare are based on WHO guidance and elements of the relevant European harmonised standards. PPE/medical devices produced under this approach for COVID-19 will not reduce the protective performance of PPE/medical devices intended to be used in health or social care settings or present additional risks to patients or health and social care workers’ safety or well-being.
The PPE/medical device must still be used in accordance with any instructions or information provided with it.
5. How long the requirements will be in place
These requirements will apply only during the continuation of the COVID-19 pandemic in the UK to ensure the ongoing and rapid provision of PPE/medical devices and ancillary products. Please also see point 9.
The impact on procurement and use of PPE and medical devices: what you need to think about
6. PPE or medical devices that are not CE marked: checking they are fit for purpose
For healthcare providers, the central purchasing teams will communicate where the relevant regulator has agreed that the PPE or medical device can be produced against the essential technical specifications and provided to the healthcare system by that named manufacturer or another source (including where it is a donation). The PPE or medical device may come with written notification of the purposes for which it can be used without having a CE mark in place. It should be clear that the product has a regulatory easement or derogation from the regulators and how it is to be used.
PPE and medical devices provided to the social care system through government supply routes will meet the standards set out above. Where social care providers are purchasing independently, they should only purchase PPE or medical devices that are CE marked for the intended purpose, or where the relevant regulator has clearly authorised its sale, donation or supply without CE marking by a specified manufacturer.
Providers can tell if a product that is not CE marked has been authorised by checking for a derogation for a medical device (such as surgical facemasks) or, where applicable, the supplier will confirm that it has a regulatory easement from HSE for PPE (such as respirators).
7. Who the essential technical requirements apply to
This essential technical requirements and supporting process applies to all manufacturers, suppliers, distributors and agents in the UK and overseas wishing to support the UK health and social care response to the COVID-19 pandemic, including through the establishment of new domestic and international contracts where their product does not have a CE mark, or where the manufacturer wishes to propose the alternative use of an existing CE marked product against the relevant legislation.
8. Existing manufacturers of CE marked PPE or medical devices
Existing manufacturers of PPE and medical devices, should continue to produce to agreed regulatory standards, including affixing the CE mark to their product as required under normal protocol and engaging notified bodies where appropriate as part of a business as usual approach. This PPE can continue to be purchased by trusts or social care providers for its intended use as part of normal procurement models within the NHS.
For CE marked PPE and medical devices, the essential technical requirements apply where the existing manufacturer wishes to propose the alternative use of that product other than that for which the CE mark was originally affixed. To use the CE marked medical device for an alternative purpose will require approval from the relevant regulator before supply, donation or sale can take place.
9. Applying the requirements directly to non-CE marked PPE/medical devices purchased or received as donations: health and social care workers
Health and social care workers or providers cannot apply the requirements. The essential technical requirements apply only to potential manufacturing for direct Government procurement or donations for frontline health and social care purposes. This can only take place where approval from the relevant regulator has been given to the provider/proposing manufacturer.
Health and social care providers cannot take action to apply the essential technical requirements directly or in isolation, given the need for regulatory approval and the associated expertise which MHRA and HSE have in place.
Health and social care providers should only purchase or receive donations of PPE/medical devices if one of the following applies:
- the donations are CE marked for the intended purpose
- they have been told that the relevant regulator has clearly authorised sale or supply without CE marking by a specified manufacturer
- they have been told the relevant regulator has authorised the sale or supply of CE marked medical devices for an alternative purpose
Manufacturers who consider they can meet the essential technical requirements are asked to ensure they have authorisation to sell, donate or supply the PPE/medical devices from the relevant regulator before doing so in order to meet the legal obligations under the relevant PPE regulations or medical device regulations.
10. Applying the requirements: providers
Health and social care providers should seek evidence that regulatory approval has been given for the sale or supply by the manufacturer of the specific PPE/medical device that does not hold a CE mark.
Providers can tell if a product that is not CE marked has been authorised by checking for a derogation for a medical device (such as surgical facemasks) here, or where applicable, the supplier will confirm that is has a regulatory easement from HSE for other PPE (such as respirators).
Where a health and social care provider has concerns that a PPE product has not been authorised by HSE they should contact HSE with details of the product.
11. What to do if you’re a health and social care provider (or another part of the health and social care system) and you’re concerned about the quality of PPE /medical devices you’ve purchased
Where there is concern that PPE or medical devices have not clearly been approved by the relevant UK regulator against the essential technical requirements, providers should check for the manufacturer and product’s MHRA derogation or request supplier confirmation that the product has a regulatory easement from HSE as described above.
Where there are significant concerns over the quality of PPE/medical devices, health and social care organisations should suspend use of that PPE where appropriate whilst an investigation or review can take place by the relevant body.
Any concerns (adverse events) with a medical device should be reported through the MHRA yellow card scheme.
For other types of PPE, where the issues are not resolved locally, they should be reported to the HSE through their Concerns and Advice Team.
If the product has come from national stock, please also log any issues using the form available on the PPE Dedicated Supply Channel website.
We are establishing a process to enable rapid regulatory approval or decision-making where the essential technical requirements are not met.
Where use of PPE/medical devices without a CE mark purchased directly by health and social care organisations is suspended, we will ensure that the relevant regulator (MHRA, HSE or both) work with the organisation to review the product against the agreed technical requirements, assisted by technical assurance teams in the UK national procurement team where necessary.
Documentation that should be provided in case of a review
For MHRA – medical devices
- Collate all evidence such as certificates, test reports, details of legal manufacturer and photos of the label/packaging
- Email firstname.lastname@example.org with the evidence collected and provide a covering note clearly identifying your concerns and state whether you are requesting a derogation or regulatory advice in the email subject title. Further guidance may be issued by MHRA
For HSE – PPE
If you want to make a complaint about a supplier or manufacturer, please detail your concerns and state that you are complaining about a supplier or manufacturer. Then contact HSE.
If you want HSE to consider a regulatory easement to allow the supply of product into healthcare, you need to gather the necessary information. Applications will only be considered by HSE if they include a minimum of:
- photographs of the PPE showing the product
- details of the manufacturer, product types and serial/model numbers of the PPE
- details of the standard or any other technical solution the product claims to be to
- copies/photos of product labels and instructions
- details of the tests carried out on the PPE
- any relevant certificates
If you do not have all of this information HSE will reject any review on the grounds that you have provided insufficient information to make a decision. Email email@example.com with the information.
This will enable consideration of:
- whether retrospective authorisation by the relevant regulator can be given to the manufacturer producing the PPE - to enable resumption of use of that PPE
- whether, in cases where retrospective authorisation cannot be given, the PPE can be authorised for the safe use in an alternative setting or purpose within the health and social care organisation
- whether, in cases where no authorisation can be given, the PPE should be permanently discontinued and destroyed
12. If your PPE/medical devices are suspended from use: making sure you have enough protection for health and care workers and patients
We are confident that centralised supply of PPE/medical devices can ensure adequate coverage in all health and care organisations during the suspension of any localised contract to purchase and whilst any assessment of suspended PPE/medical devices takes place. In this scenario social care providers are recommended to use one of the emergency supply routes to ensure sufficient PPE/medical devices.
13. Donations and the requirements
To protect UK patients and health and social care workers it is critical that health and social care organisations only accept donations of PPE/medical devices:
- that are CE marked for the intended purpose specified in the user instructions; or
- the regulator has authorised the supply of CE marked medical devices for an alternative purpose; or
- where they have been advised that the relevant regulator has authorised its supply without CE marking
14. The government’s position on donating PPE/medical devices
The essential technical requirements and supportive process to enable regulatory approval to be secured applies to both national purchasing and to donations. The process ensures patient and health and social care worker safety is prioritised whilst enabling those who wish to donate or produce new PPE/medical devices to those standards to put forward their proposals in a streamlined and accessible way.
15. What to do if you’re a health and social care provider concerned about counterfeit or suspected counterfeit PPE/medical devices which are in use or potentially going to be used
Where there are concerns over the quality of PPE/medical devices in use (including where they have not clearly undergone, and passed conformity assessment or been approved by the relevant UK regulator) health and social care organisations should consider suspension of use whilst regulatory review can take place. This includes where there is strong suspicion or confirmation that the PPE/medical device is counterfeit. Concerns could be about the claimed CE marking, supporting documentation or claims on use being presented by a manufacturer not known by the health or social care organisation or other part of the health and social care system. In such cases you can contact the relevant regulator providing supporting evidence as outlined in point 11. We therefore also recommend health and social care providers create a business-wide mechanism to raise concerns and enable a centralised engagement with government purchasing and the regulators.
16. What regulators will do if counterfeit PPE is identified and its use is suspended
If a manufacturer of a medical device claims that their product is compliant to affix a CE mark but is breaching the regulations, they will be contacted by the MHRA compliance unit who will outline their concerns and request further information.
The MHRA administers and enforces the law on medical devices in the UK. It has a range of investigatory and enforcement powers to ensure their safety and quality. This includes the power to suspend the sale of medical devices not marketed in accordance with regulatory requirements.
These powers also apply to those medical devices which are not CE marked and do not have regulatory approval (derogation) from the MHRA to supply.
Personal protective equipment
If a manufacturer claims to hold a valid CE mark for PPE, enforcement authorities in the UK such as trading standards authorities and the HSE), will be able to take action against ‘economic operators’ (i.e. manufacturers, importers and distributors) if they do not comply with the obligations in EU PPE regulations.
17. How regulators will decide who is responsible if PPE/medical devices are bought and used/continue to be used and do not meet the essential technical requirements or are counterfeit
Any individual, health or social care provider knowingly using PPE/medical devices which do not have a valid CE mark or regulatory approval as described above does so with potential risk to the patient and/or the health and social care worker using that PPE/medical device. Under health and safety law, the employer is responsible for ensuring that any PPE/medical device provided for use at work is adequate, suitable and safe.
Manufacturers of PPE/medical devices who sell or supply this to health and care providers without regulatory approval against the essential technical requirements are in breach of UK and EU law and could be subject to enforcement action in the same way as those who sell or supply counterfeit PPE/medical devices.
The regulators will, as required, take action to remove PPE/medical devices/ from use or sale where this continues to be supplied or sold outside of the agreed regulatory standards. The regulators will consider enforcement action where appropriate.
The safety of health and social care workers and patients across the UK, including in the devolved administrations, is critical.
To enable this, it is imperative that CE marked PPE (including where it is a medical device) are purchased or donated as a priority.
Where this is not feasible, any rapid production and supply/sale of new PPE/medical device that does not have a CE mark or has an alternative use of an existing CE marked product must meet the essential technical requirements agreed by the UK regulators; the Health and Safety Executive (HSE) and the Medicines and Healthcare Products Regulatory Agency (MHRA). Authorisation from the regulator must be obtained by the manufacturer before products can be purchased by or donated to the government/NHS and other health care users.
Decisions to authorise named manufacturers to supply/sell PPE/medical devices produced against these essential technical requirements will inform both national and local procurement.
For national procurement, these essential technical requirements are now embedded into buying decisions and reviews of national stock which does not hold a CE mark, with technical assurance leads working closely with the UK regulators.
It’s now critical that the centre works in partnership with health and social care providers to communicate details about those authorisations to manufacturers to supply or sell PPE/medical devices against the essential technical requirements. This will ensure local procurement is informed and adheres to the essential technical requirements.
Where PPE/medical devices have currently been purchased or supplied locally as non-CE marked products and there is doubt as to the manufacturer’s/provider’s compliance with the essential technical requirements, use should be suspended whilst a review takes place in partnership with the relevant UK regulator. MHRA publishes authorisations (derogations) for medical devices following a robust review of the evidence supplied by the manufacturer. Where applicable suppliers should confirm that PPE have a regulatory easement from HSE and that they meet the essential health and safety requirements (EHSRs) using the essential technical requirements. However, purchase of CE marked PPE/medical devices must be the priority.
We will seek internal review by health and social care providers of any PPE/medical devices in relation to which there may be doubt as to compliance with the essential technical requirements, so that review in partnership with the UK regulators can take place.
The use of PPE/medical devices that are not CE marked should be prioritised, so that these stocks are used up first.