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.