01 July, 2020
The Covid-19 crisis had led to extraordinary measures being taken by product manufacturers across the globe. In the UK, we have seen many businesses adapting production capability away from their usual products to help deal with the lack of supply of certain medical products and PPE. We are also seeing an increase in businesses creating new products to limit the spread of coronavirus, such as face coverings and foot operated hand sanitiser dispensers.
The Medicines and Healthcare Products Regulatory Agency (MHRA), and the Health and Safety Executive (HSE), who are the UK authorities responsible for regulating medical devices and PPE respectively, have produced guidance documents for businesses which manufacture these products. The authorities have also announced broad-ranging exemptions to the regulations, to combat the lack of supply and speed-up the manufacture process.
In relation to PPE, there have been relaxations of the usual requirements when it is used in connection with Covid-19 to the extent that if PPE is made to the relevant standard and is for supply to the NHS/healthcare workers via the UK Government, it will not need to undergo CE assessment via a notified body. However, it will still need to be assessed by a Cross Government Decision Making Committee and the UK Government has published guidance on the technical specifications for various types of PPE.
Where PPE is produced for other workers outside the healthcare setting, it would still need to be assessed by a notified body, although a 'fast-track process' has been introduced. Again, the UK Government has published guidance for new high-volume manufacturers of PPE on how the procedures for conformity assessment will apply.
Whilst new products developed to prevent the spread of coronavirus may not be classified as medical devices or PPE, and therefore not regulated by the MHRA or HSE, different regulations may apply. For example, face coverings intended for use by the general public are not classed as PPE, however if a business does wish to sell face coverings, they must meet the existing requirements of the General Product Safety Regulations 2005 (GPSR).
In these unprecedent times, the regulatory landscape is changing daily, and businesses must monitor and adapt to changes when they occur. The HSE have indicated that straying from the requirements set out in legislation will not be tolerated and businesses which supply non-compliant products could face penalties.
For more information contact John Pickervance in our Manufacturing & Engineering department via email or phone on 0333 207 1134. Alternatively send any question through to Forbes Solicitors via our online Contact Form.