Compassionate Use and Temporary Use of a medical device
Easement or relaxation of certain regulatory requirements
Relaxation of certain regulatory requirements (‘easement’) was well recognized and utilized for devices (e.g., masks, gloves, ventilators) and IVD’s such as lateral flow tests during the earlier phases of the SARS-CoV-2 pandemic.
But did you know that in certain cases, medical device regulatory requirements may also be relaxed when outside the scope of the covid pandemic?
In certain circumstances where a suitable product or device is not currently available to protect a patient’s health, a non-compliant medical device may be authorized for use under the terms of ‘compassionate use’ or a device may be used not as intended under the term ‘off label’ use.
Compassionate Use and Temporary Use of a medical device
The MHRA may authorise manufacturers to supply a non-compliant device in the interest of the protection of health.They can proceed under Regulation 12(5) of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). This also applies for active implantable medical devices in regulation 26 and for in vitro diagnostic medical devices under regulation 39(2).
Criteria for exceptional use of non-complying medical devices
A manufacturer may be able to supply a non-complying medical device for the treatment of a single named patient in exceptional circumstances if:
- the clinician responsible for the patient’s treatment supports the manufacturer’s application
- there is no alternative UKCA marked device available for this treatment
- it can be demonstrated that mortality or morbidity is significantly reduced if the device is used compared to alternative compliant treatment
The manufacturer has the responsibility to apply to supply a non-compliant medical device. However, the manufacturer and the clinician must both complete the required forms listed on the application and submit them to the MHRA. Separate applications are required for different patients on a case-by-case basis.
Application by be made through the MHRA’s ‘Humanitarian Use of a device – application form’ and then emailed to email@example.com
Link to form: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/948315/Application_form_humanitarian_use.doc
The MHRA will then begin their assessment and contact the manufacturer or clinician if any information is unclear or if further details are needed.
MHRA aim to make a decision with 48 hours and if approval is granted, this may also come with defined obligations for the manufacturer and clinician.
Generally, the device must be approved on a case-by-case basis and for each use. However, where a device is likely to be applied on multiple occasions or in cases where emergency stock is needed to be held, MHRA may also give this approval, but only in rare cases.
Off-label use of a medical device
Medical devices should always be used as described and as intended by the manufacturer. This should be clear on the device, on the packaging and in the instructions. But if you use the device in any other way, it’s considered ‘off-label’ use.
Examples of ‘off-label’ use could include the sterilisation and re-use of a single use device, such as a syringe. Any company that reprocesses the device in this way effectively becomes a manufacturer. Without the manufacturer’s approval this will be at your own risk and the responsible party would become liable for civil claims for damages from injured patients or their families if something goes wrong with the device.
Off-label use of a device could lead to dangers including:
- adverse reactions
- inadequate sterilisation
- insufficient mechanical strength and/or structural integrity
- insufficient durability
- misuse due to lack of adequate training for the device
Although rare, it is possible that there is no medical device available for a specific procedure. In this case it should be determined whether an existing medical device could or should be used for a different purpose. Or if the device should be modified for a new purpose. Or use a product for a medical purpose that is not CE or UKCA marked as a medical device.
First, you must balance the risks and benefits to the patient taking into account recommendations which include:
- carrying out a risk assessment and documenting it
- considering the ethical and legal implications
- implementing suitable precautions to minimise the risk
- reviewing the risk assessment at suitable periods
- getting approval from MHRA for exceptional use of non-complying devices (if necessary)
The patient must be fully informed during the consent procedure and notes on their records should record who used and how they used that medical device ‘off-label’.
Some devices are designed to be modified. Manufacturers will provide instructions if a medical device can be modified in a specific way, for example orthotics.
Manufacturers will sometimes supply software updates or hardware modifications to improve the performance of a medical device or to correct a problem. They will either make the change themselves or provide detailed instructions for the user to make the modifications. These aspects are not considered as ‘off-label’ use.
If you want to know more about medical devices which could be used for compassionate use or which may intended to be used ‘off-label’, you can come and talk to the team at IMed Consultancy and we will be pleased to guide you https://imedconsultancy.com/
MHRA Guidance: Exceptional use of non-UKCA marked medical devices
MHRA Guidance: Off-label use of a medical device
Strategic Development Director