Fast-track approval of medical devices during COVID-19 outbreak.
In this exceptional situation, MHRA may authorise you to supply a non-CE marked device in the interest
of the protection of health.
This will be under regulations 12(5), 26(3) and 39(2) of the Medical Devices Regulations 2002.
Personal Protective Equipment (PPE)
Refer to the following OPSS coronavirus (COVID-19) guidance for business and local authorities and in
particular the Q&A for manufacturers of Covid-19 PPE – meeting the requirements.
Approval from Department of Health and Social Care (DHSC)
First check the specifications needed, then contact the DHSC for their approval on firstname.lastname@example.org.
Apply to MHRA for exemption from the regulations
If DHSC has approved your medical device
Send us your application for exemption from the regulations (derogation).
Sending your application to MHRA
If you manufacture other medical devices such as surgical (medical) face masks, examination or surgical gloves,
send your application directly to MHRA. You don’t need DHSC approval first.
Send your application to email@example.com.
Include the following information in your email:
- details of the product(s) (including model name, description and intended purpose of use)
- reasons why the product does not have a valid CE mark
- clinical justification for requesting an exemption from the regulations for the product
- explanation of any alternative products on the market and reasons why using these products would not be appropriate
- numbers of product likely to be supplied under the exemption, plus an indication of how widely used the product is
- expected time to gain/re-gain CE certification
We might ask you for more information once we’ve received your application.
Be aware that you are expected to have evidence that the device performs as intended. For example,
performance data such as bench testing (including any that comply with a relevant standard – harmonised or
other) and any study data you have.
To create more flexibility for manufacturers and availability of medical devices, we would not expect to receive a
request for derogation of a CE-marked device where there is limited change to its intended use. For example,
changing its use from ward use to include intensive care use. However, you should perform a risk assessment and
contact your notified body for advice in the first instance.
We expect to receive a high volume of applications for derogations.
We will prioritise applications based on the needs of the healthcare providers to increase the supply of critical devices and tests.
See MHRA guidance on COVID-19.
Published: 27th March 2020
Source: GOV UK
Page URL: https://www.gov.uk/guidance/exemptions-from-devices-regulations-during-the-coronavirus-covid-19-outbreak?utm_source=7ead65cf-4a99-4da9-a410-1eb83ef85997&utm_medium=email&utm_campaign=govuk-notifications&utm_content=daily