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Covid-19 regulatory and industry guidance

Posted on 01/04/2020

KTN has assembled a list of regulatory and industry guidance around Covid-19 for companies working in health and/or manufacturing health equipment.

If you are considering manufacturing a product that is new to your company, please also consult our round-up of product specifications (including UK government publications) and feel free to contact our Health and/or Manufacturing teams for advice. You may also find our Covid-19 funding round-up useful.

Most recent update: 20th April 2020.

 

Regulatory guidance

Regulatory approval for Coronavirus test kits (How manufacturers can submit test kits for approval to MHRA)

MHRA guidance on Coronavirus (Covid-19)

Exemptions from Devices regulations during the coronavirus (Covid-19) outbreak

Regulatory status of equipment being used to help prevent coronavirus COVID19, including hand sanitisers / gels and PPE

MHRA regulatory flexibilities (including CE marking exemption) resulting from Covid-19

Guidance on coronavirus (Covid-19) tests and testing kits (serology point of care tests and self-tests)

OPSS Guidance for new high volume manufacturers of Covid-19 Personal Protective Equipment

Guidance on infection prevention and control for Covid-19

HSE Coronavirus (Covid-19): latest information and advice

BSI ventilator standards listing (accessible free of charge)

PPE regulations – legislative guidance for businesses

Institute for Food Science and Technology (IFST) knowledge hub

Further information from KTN

Covid-19 hub page

Covid-19: response from KTN

Covid-19: round-up of initiatives and resources

Covid-19 National Contact points

Covid-19 – Help and support for businesses

Covid-19 product specifications

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