This page was updated on 16 July 2021.

Guidance for manufacturers - Valid from 19 July 2021

Businesses must carry out an appropriate risk assessment including the risk from COVID-19, just as with other H&S related topics. This must be done in consultation with unions or workers. You should share the risk assessment with your employees. More information on risk assessments and what to include in these can be found on the Health and Safety Executive's page. 

Government guidance does not supersede any legal obligations relating to H&S, employment or equalities. Businesses must continue to comply with existing obligations including those relating to individuals with different protected characteristics.

To support you to continue operating safely and ensure the health and safety of your colleagues and customers, we have collated a range of tools and resources, which can be accessed here. 

Additional Resources

Latest Government Guidance  

• Guidance outlining how the government will undertake the desktop review of COVID-19 detection tests submitted for assessment under the Coronavirus Test Device Approvals Regulation has been published. View here (17 August). 
• The list of devices with exceptional use authorisations as well as those no longer covered has been updated. View here (11 August).
• The government has published guidance on how test manufacturers or distributors can apply for approval of their tests to sell on the UK market. View here (28 July).
• The list of medical devices given exceptional use authorisations during the COVID-19 pandemic by the MHRA has been updated. View here (20th July).
• The list of devices with exceptional use authorisations as well as those no longer covered has been updated. View here (14 July).
• The list of devices with exceptional use authorisations as well as those no longer covered has been updated. View here (21 June).
• Updated the ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ document to update the ‘Validation stage’ table. View here (15 June). 
• The ‘Validated technology’ table was updated in the ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ to add 3 new tests: Certest Biotech Viasure qRT-PCR, Randox Rapid PCR and Thermo Fisher Taqpath PCR. View here (3 June). 
• Updated list of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. View here. (27 May).
• Updated list of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. View here. (13 May).
• Updated lists of medical devices with exceptional use authorisations by the MHRA and those no longer covered. View here (6 May).
• Updated ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ to add detail on performance results in the ‘Validated technology’ section. View here (4 May).
• The MHRA has defined common terms related to COVID-19 testing following requests from a range of stakeholders including manufacturers considering developing new COVID-19 rapid lateral flow tests during the COVID-19 pandemic. View here (27 April).
• Updated lists of medical devices with exceptional use authorisations by the MHRA and those no longer covered. View here (26 April).
• Updated the ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ document to update the ‘Validation stage’ table. View here (22 April).
• Updated lists of medical devices with exceptional use authorisations by the MHRA and those no longer covered. View here (20 April).
  
• Updated lists of medical devices with exceptional use authorisations by the MHRA and those no longer covered. View here (19 April).
• Updated the attachment ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ to update the products in the pipeline table. View here (7 April). 
• Updated the ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ document to add new validated technology, ‘DNANudge’. View here (6 April)
• Version 3 of the guidance for all manufacturers of PPE published, was amended to reflect the end of the conformity assessment easing in relation to the placing on the GB market of COVID-19 related PPE. View here (1 April).
• Updated lists of medical devices given exceptional use authorisations by the MHRA during the COVID-19 pandemic. View here (30 March).
• Updated the attachment ‘National standardised test performance process for manufacturers of SARS-CoV-2 virus antibody tests’ to update the products in the pipeline table. View here (30 March).
• Updated lists of medical devices with exceptional use authorisations by the MHRA and those no longer covered. View here (24 March).
• Updated the National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests document to add information about antibody test manufacturers. View here (17 March)
• Updated the ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ document to update the ‘Validation stage’ table. View here (5 March).
• Updated lists of medical devices with exceptional use authorisations by the MHRA and those no longer covered. View here (2 March).
• COVID-19 Tests and Testing Kits: The document for industry and manufacturers has been updated to include the new UKCA, CE and CE UKNI markings. View here (24th February).
• Updated lists of devices with exceptional use authorisations by the MHRA and those no longer covered. View here (24th February).
• Updated lists of devices with exceptional use authorisations by the MHRA and those no longer covered. View here (9th February).
• Updated the ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ document to add 2 new validated technologies, ‘LumiraDx: POC rapid COVID-19 Ag test’ and ‘Primer Design Ltd: PROmate direct: qRT-PCR’. View here (3rd February)

• Updated ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ to reflect the number of technologies currently in the TVG pipeline. View here (1st February).

• Updated lists of devices with exceptional use authorisations by the MHRA and those no longer covered. View here (1st February).

• Specification for Rapidly Manufactured CPAP System to be used during the coronavirus (COVID-19) outbreak was updated to reflect changes to regulations following Brexit transition. View here (28th January)
• An updated list of medical devices no longer covered by an exceptional use authorisation has been added. View here (18th January)
• Updated lists of devices with exceptional use authorisations by the MHRA and those no longer covered. View here (15th January).
• Letter to those working in the manufacturing sector by the Secretary of State, Department for Business, Energy & Industrial Strategy was published. View here (11th January)
• Updated ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ to clarify the procurement process and to reflect the number of technologies currently in the TVG pipeline. View here (11th January).
• Updated the ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ document to add a new validated technology, Abbott. View here (8th January). 
• Updated the ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ document to delete a validated technology (Latus) and add a new validated technology (Nonacus). View here (8th January)
• Updated list of medical devices that have received exceptional use authorisations by the MHRA. View here (8th January)
• Updated the ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ document to update the ‘Products in the pipeline’ table and add a new validated technology, Latus. View here (7th January).
• Updated lists of devices with exceptional use authorisations and those no longer covered. View here (4th January).
• Letter to those working in the manufacturing sector by the Secretary of State, Department for Business, Energy & Industrial Strategy was published. View here (December 2020)
• Updated ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’: added guidance for antibody test manufacturers about registering interest; added that an alternative technical validation route will be required for any non-machine based LFT and home testing kits; and removed Tenders Electronic Daily as a source of further procurement opportunities. View here (23rd December).
• How tests and testing kits for coronavirus (COVID-19) work - Updated guidance on submitting proposals for antibody tests in the attachment ‘For industry and manufacturers: COVID-19 tests and testing kits’. View here (23rd December). 
• Updated list of medical devices that have received exceptional use authorisations. View here (23rd December). 
• Updated ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ to reflect the number of technologies currently in the TVG pipeline (22nd December).
• Updated ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’ to add a new validated technology (QuantuMDx), edited links under ‘Publication of results’ and amended title of ‘First wave of non-machine based lateral flow technology (LFT) assessment’ to ‘First wave of lateral flow test and non-machine based LFT assessment’. View here (17th December). 
• Updated list of medical devices that have received exceptional use authorisations as well as those that are no longer covered. View here (9th December). 
• National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests - updated information about technologies in the pipeline, added new information about validations concluded or paused and added new information and reports on validated technology. View here (7th December)
• Guidance for manufacturers and makers of face visors added on complying with the General Product Safety Regulations 2005. View here (2nd December)
• Updated list of medical devices that have received exceptional use authorisations as well as those that are no longer covered. View here (1st December). 
• Prime Minister announces £20m to grow medicines manufacturing in the UK. View here (30th November). 
• MHRA scientific and regulatory advice for COVID-19 vaccine developers. View here (23rd November). 
• Devices covered by exceptional use derogations, as well as those no longer covered have been updated in the list of manufacturers and their medical devices which have been granted an exemption by the MHRA -  View here (17th November).
• Coronavirus (COVID-19): letter from the Secretary of State for Business, Energy and Industrial Strategy, Alok Sharma to the manufacturing sector, November 2020. View here (13th November) 
• Updated list of medical devices that have received exceptional use authorisations as well as those that are no longer covered. View here (11th November). 
• Clinical trials applications for Coronavirus (COVID-19) - The government has added a new section on COVID-19 trial related activity, and added a new email address to contact the clinical trials unit on: Covid.clinicaltrials@mhra.gov.uk. View more here (9th November). 
• Updated list of medical devices that have received exceptional use authorisations as well as those who are no longer covered. View here (6th November). 
• The temporary VAT zero rate applying to supplies of PPE as defined by Public Health England’s coronavirus (COVID-19) PPE guidance on 24 April 2020 has ended. View here (1st November) 
• Devices with an exceptional use derogation, as well as those no longer covered have been updated in the list of manufacturers and their medical devices which have been granted an exemption by the MHRA -  View here (28th October).
• Assessment and procurement of coronavirus (COVID-19) tests - Updated information about technologies in the pipeline in ‘National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’. View here (23rd October). 
• List of manufacturers and their medical devices which have been granted an exemption by the MHRA has been updated with new additions and expired authorisations. View here (20th October).
• List of manufacturers and their medical devices which have been granted an exemption by the MHRA has been updated with new additions and expired authorisations. View here (13th October).
• List of manufacturers and their medical devices which have been granted an exemption by the MHRA has been updated with new additions and expired authorisations. View here (6th October). 
• Version 7 of the guidance for new high-volume manufacturers of PPE and version 4 of the guidance for businesses and individuals on the small-scale manufacture of PPE published, have been amended to simplify the text concerning the Market Surveillance Authority approval of PPE. View here (30th September). 
• List of manufacturers and their medical devices which have been granted an exemption by the MHRA has been updated with new additions and expired authorisations. View here. (29th September).
• Version 4 of the guidance for manufacturers and makers of face coverings on complying with the General Product Safety Regulations 2005 published, has been amended in light of the alignment of approach across the UK, and with a warning against claiming that face coverings containing particulate material 2.5 filters or other hygiene filters give protection from COVID-19. View here (23rd September).
• The guidance on testing kits has been re-written for both patients and the public and for manufacturers to make it clearer to understand. View here (22nd September). 
• List of manufacturers and their medical devices which have been granted an exemption by the MHRA has been updated with new additions and expired authorisations. View here. (22nd September).
• List of manufacturers and their medical devices which have been granted an exemption by the MHRA has been updated with new additions and expired authorisations. View here. (15th September).
• Version 4 of the guidance for businesses on the Personal Protective Equipment (PPE) Regulations, version 6 of the guidance for new high-volume manufacturers of PPE and version 3 of the guidance for businesses and individuals on the small-scale manufacture of PPE have been published. Read more here (2nd September).
• Added the following 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'. View here. (28th August).
• List of manufacturers and their medical devices which have been granted an exemption by the MHRA has been updated with new additions and expired authorisations. View here. (28th August).
• New state-of-the-art centre to scale up COVID-19 vaccine and gene therapy manufacturing gets £100 million investment. Read more here (23rd July).
• COVID-19: guidance for food businesses (intended for all workplaces involved in the manufacturing, processing, warehousing, picking, packaging, retailing and service of food) - Updated guidance, added easy-to-translate guide and link to posters. View here (22nd July).
• Guidance for manufacturers and makers of face coverings to comply with the General Product Safety Regulations 2005, Version 3 published. Download here (13th July).
• New Small-Scale Manufacturers of COVID-19 Personal Protective Equipment (PPE) - Version 2 published. Download here (13th July).
• New High-Volume Manufacturers of COVID-19 Personal Protective Equipment (PPE) - Version 5 published. Download here (13th July)
• MHRA regulatory flexibilities - Added information for manufacturers of human plasma-derived medicines during the coronavirus (COVID-19) outbreak. View here (13th July).
• Exceptional GMP flexibilities for medicines manufacturers during the coronavirus (COVID-19) outbreak - Update: Removed information about medicines being marketed outside the UK. View here (13th July). 
• Information for clinical diagnostic laboratories regarding safety, sampling and packaging specimens associated with COVID-19 - Update section on laboratory investigations and sample requirements for diagnosis. View here (7th July)
• Ventilator Challenge hailed a success as UK production finishes. View story here (4th July).
• Manufacturers and suppliers of thermal cameras should not make claims which directly relate to COVID-19 diagnosis - Read more (3rd July)
• List of manufacturers and their medical devices which have been granted an exemption by the MHRA. View here (29th June). 
• Regulatory status of equipment being used to help prevent coronavirus (COVID-19) - Added explanations about the regulations around face coverings. Read more here (29th June). 
• Guidance for all workplaces involved in the manufacturing, processing, warehousing, picking, packaging and retailing of food. View here (26th June).
• Updates have been published to the departmental minute outlining indemnities granted to designers and manufacturers in the Rapidly Manufactured Ventilator System Project. View here (23rd June).  
• How to get fast-track approval of medical devices during COVID-19 - Updated list of information to include in an email application.Read more here (17th June). 
• Guidance for manufacturers and makers of face coverings to comply with the General Product Safety Regulations 2005, Version 2. View here (9th June). 
• Target Product Profile: enzyme immunoassay (EIA) antibody tests to help determine if people have antibodies to SARS-CoV-2. Read more here (5th June).
• Medical devices: Audits of Notified Bodies and manufacturers. View update here (5th June).
• Coronavirus support from Business Representative Organisations and Trade Associations: Engineering and Manufacturing. View here (4th June).
• 3D printing (additive manufacturing) of medical devices or component parts during the coronavirus (COVID-19) pandemic. Read more here (4th June).
• How the government assesses offers of COVID-19 tests from developers for procurement and use in the UK. View here (3rd June).
• Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak. Read more here (29th May).
• Guidance for manufacturers and makers of face coverings. Read more here (28th May).
• Exporting personal protective equipment during coronavirus (COVID-19): Goods exported from the European Union after midnight on Monday 25 May 2020 will no longer require an export authorisation. Read more here (28th May).
• Funding and manufacturing boost for UK vaccine programme. Read more here (17th May).
• Guidance for industry and manufactures: COVID-19 tests and testing kits. Read more here (13th May). 
• Guidance for people who work in or run factories, plants and warehouses during the Coronavirus. Read more here (11th May).
• New reagent available to support global diagnostic testing of coronavirus (COVID-19). Read more here. (6th May). 
• Government has added a link to a new dedicated Yellow Card coronavirus website for reporting any incidents involving medical equipment relating to COVID-19 treatment (5th May). Read more here. 
• Notification of contingent liability: Rapidly Manufactured Ventilator System Project. Read more here (29th April). 
• Personal protective equipment (PPE): export control process. Updated to reflect new EU regulation and added to list of other territories. Read more here (26th April).
• Exceptional GMP flexibilities for medicines manufacturers during the coronavirus (COVID-19) outbreak. Read more here (22nd April).
• Coronavirus (COVID-19): ventilator supply specification - (14th April).
• Coronavirus (COVID-19): personal protective equipment (PPE) hub. View here (10th April).
• Government sets out plan for national effort on PPE - Press Release (10th April). 
• Notice to exporters 2020/10: processing licence applications during coronavirus (COVID-19). Read more here (9th April).
• Coronavirus (COVID-19): how laboratories can support the testing programme. Read more here (9th April).  
• Offer coronavirus (COVID-19) support from your business. Read more here.
• Help the government increase coronavirus (COVID-19) testing capacity. Read more here (8th April).
• Coronavirus (COVID-19): letter to the manufacturing sector from the Secretary of State for Business, Energy and Industrial Strategy, Alok Sharma. Read here (8th April).
• Advice for employers on social distancing during coronavirus (COVID-19) - Manufacturing and processing businesses. Read more here (7th April).
• Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak. Read more here (7th April).
• Technical Specifications for Personal Protective Equipment (PPE). View here (6th April).
• Forms for organisations that can manufacture and supply testing consumables, equipment and laboratory PPE as part of the coronavirus (COVID-19) response can be found here (3rd April).
• Personal protective equipment (PPE): export control process. Guidance can be seen here (2nd April).
• COVID-19: Call for rapid sanitising technology for ambulances. More information here (2nd April).
• Specification for Rapidly Manufactured CPAP System to be used during the coronavirus (COVID-19) outbreak. Read more here  (29th March).
• Government to ease regulations to ensure hand sanitiser and personal protective equipment reaches NHS staff quickly, read more here (28th March).
• Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak. Read more here (26th March).
• Guidance for Manufacturers Specials licence holders on ‘packing down’ medicines during the coronavirus (COVID-19) outbreak. Read more here (25th March).
• How to place a Coronavirus (COVID-19) test kit on the market. Read more here (25th March).​

•  All guidance to Medicines and Healthcare products Regulatory Agency on coronavirus (COVID-19), including Clinical trials, Inspections, Medical devices, Medicines and COVID-19, Medicines regulation can be found here (19th March).​

More information is available on the UK Government’s Coronavirus Business Support website. For more personalised advice call us on: 0161 237 4128 or email us at: BGH@growthco.uk 

The information provided is meant as a general guide only rather than advice or assurance. GC Business Growth Hub does not guarantee the accuracy or completeness of this information and professional guidance should be sought on all aspects of business planning and responses to the coronavirus. Use of this guide and toolkit are entirely at the risk of the user. Any hyperlinks from this document are to external resources not connected to the GC Business Growth Hub and The Growth Company is not responsible for the content within any hyperlinked site.