The battle against COVID leads to regulatory changes. The UK, as well as many others, is trying to combat the virus with all its strength and, to do so, needs a non-stop chain of medical devices arriving to its coasts.
To this end, the MHRA has accelerated the procedure for Medical Devices to enter the UK market. As such, manufactures have been entitled to obtain exemptions from certain regulations applicable to their medical devices.
However, how to get an exemption[1] will depend on what you are manufacturing. Do you want to get in touch with the novelties? This article is for you!
The government of the UK has published on its official website some regulatory flexibilities resulting from coronavirus, check below the most relevant for medical devices:
- To significantly reduce the assessment time frames and to ensure and agile process;
- To focus on and prioritize COVID-19 testing and personal protective equipment (PPE);
- To maintain a flexible and pragmatic approach to the regulatory requirements for clinical investigations, while using the expedited review for those related to COVID-19:
– Protocol deviations as a result of COVID-19 do not need to be notified to MHRA, unless there is an impact onto patient safety; - Specifications for CPAP and ventilators aimed to ensure a continued supply of these devices during the crisis have been issued as well.
Remember, if you manufacture other COVID-19 related medical devices different from tests or ventilators, you can apply directly to the MHRA. This is the case of, for example, surgical face masks, tests or surgical gloves.
How can you do it? Send your application to devices.exceptionaluse@mhra.gov.uk!
The following must be included in your application:
- 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;
- Instructions for use/labelling plus relevant marketing material;
- The clinical evidence base – performance study report, other studies, literature etc;
- Details of other regulatory approvals;
- Confirmation that you successfully completed this survey;
- 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.
In addition to the above, the manufacturer is expected to have evidence about the devices’ intended performance. Data study and bench testing are examples of such evidence.
29/04/2020
Carlos Francisco Marín Barrios
Regulatory Affairs Department
For further information on COVID-19 contact our experts at Obelis.net!
[1] Exemptions under regulations 12(5), 26(3) and 39(2) of the Medical Devices Regulations 2002.