How to get fast-track approval of medical devices during COVID-19.
Due to the COVID-19 outbreak, you may be able to get exemptions from certain regulations for your medical device.
How to get an exemption will depend on what you are manufacturing.
Approval for ventilators, PPE and COVID-19 testing kits
There is specific guidance and routes to follow for these types of devices.
Once you get approval, you can send us your application for exemption from the regulations.
Personal Protective Equipment (PPE)
If you are manufacturing PPE, see the 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.
We have produced guidance on who regulates different sorts of PPE.
Tests and testing kits for COVID-19
We have produced separate guidance for COVID-19 tests and testing kits including a specification.
Software products specifically intended to read lateral flow tests
We have produced separate guidance to indicate the extra information to support applications for software specifically intended to read lateral flow tests.
Exemptions for all other kind of medical device
If you manufacture other medical devices such as surgical (medical) face masks, examination or surgical gloves, apply directly to the MHRA.
How to apply to the MHRA
Send your application to email@example.com.
Include the following information in your email:
- for PPE/Protective MD applications only - Confirmation of whether the product is intended to protect the user, the patient or both
- confirmation of the role of the applicant:
- whether the applicant is the legal manufacturer for the medical device
- if the manufacturer is outside of the UK please provide the details of the UK Responsible Person or Northern Ireland-based Authorised Representative (for applications for the Northern Ireland market only)
- confirmation that the product is intended for the Great Britain market, Northern Ireland market, or both
- details of the product(s) (including model name, description and intended purpose of use)
- impact in the context of the COVID-19 pandemic:
- clinical justification for requesting an exemption from the regulations
- evidence of demand for the device e.g. evidence of a purchase order/enquiries from NHS or government for you to supply
- reasons why the product does not have a valid CE, CE UKNI or UKCA mark
- an essential requirements checklist demonstrating how the device meets appropriate standards. Where standards are not met a rationale/plan should be provided
- evidence of ISO 13485 certification or equivalent
- evidence of regulatory approval of the product within other jurisdictions e.g. FDA etc
- explanation of any alternative CE, CE UKNI or UKCA marked products on the UK 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, CE UKNI or UKCA certification
- instructions for use/labelling plus relevant marketing material
- the clinical evidence base - clinical studies, literature etc
- a detailed plan on how the manufacturer will demonstrate compliance or withdrawal of the device from the market after the temporary derogation expires.
You are expected to have evidence that the device performs as intended. For example, you should include performance data such as bench testing (including any that comply with a relevant standard – designated, harmonised or other) and any study data you have.
We will be granting any exemptions under regulations 12(5), 26(3) and 39(2) of the Medical Devices Regulations 2002.
Limited changes to use for medical devices
To create more flexibility for manufacturers and availability of medical devices, we would not expect to receive a request for derogation of an existing 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.
What we will do with exemption applications
We might ask you for more information once we’ve received your application.
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 Medical devices given exceptional use authorisations during the COVID-19 pandemic for a list of manufacturers and their medical devices which have been granted an exemption by the MHRA..