Essential technical requirements for new, high-volume manufacturers of COVID-19 Personal Protective Equipment (PPE)
The following guidance applies only to potential manufacturing for direct Government procurement or donations for frontline health and care purposes.
It is designed for businesses that want to make and supply high volumes of gowns, gloves, masks, respirators, eye protection, aprons and coveralls.
It sets out the technical requirements based on what is ‘minimally acceptable’ for manufacturer in the context of the COVID-19 threat, whilst maintaining essential safety requirements and how to then apply for an exemption to the MDR or regulatory flexibilities for PPE.
To view the Personal Protective Equipment essential requirements, click here, and view pages 15-23.