Most PPE is not classified as a medical device because it is designed to protect the user not the patient. It is only a medical device if the intended use is to protect the patient and the user (e.g. mask used by a surgeon during an invasive procedure)
Here is the MHRA guidance on the topic: https://www.gov.uk/guidance/regulatory-status-of-equipment-being-used-to-help-prevent-coronavirus-covid-19
Here is a summary of the situation with non-medical device PPE approval for non-CE Marked products:
- Office for Product Safety & Standards are the policy lead for PPE safety policy in BEIS
- Health & Safety Executive are the market surveillance authority responsible for enforcement of safety requirements for PPE used in the workplace.
- Procurement of PPE for COVID-19 is being led by the Cabinet Office: gcfcovid19enquiries@cabinetoffice.gov.uk
Rapid approval process in development:
- PPE would normally require 3rd party conformity assessment by a Notified Body (e.g. British Standards)
- A simplified process has been agreed but all PPE must still meet Annex II: Essential Health & Safety Requirements as set out in Regulation (EU) 2016/425 on personal protective equipment (Download Document)
- HSE and Conformity Assessment Bodies will prioritise assessment of PPE and process still in development.
For the companies with enclosure devices, careful consideration should be given to the type of polymer used given the potential for an oxygen rich environment (lots of ventilators). For example, anaesthetic breathing machine casings are typically made from PVC. The higher the LOI the better.
Download Flammability of polymers
