Exceptional use of non-CE marked medical devices
- Medicines and Healthcare products Regulatory Agency
- Part of:
- Regulatory guidance for medical devices, Patient safety, and Medical devices regulation and safety
- 18 December 2014
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
A manufacturer can apply to supply a medical device that does not comply with the law to protect a patient’s health if there is no legitimate alternative available. This is called an exceptional use of a non-CE marked medical device. The same provision may be made for custom-made devices that have not complied with the standard conformity assessment procedure.
MHRA may authorise manufacturers to supply a non-compliant device in the interest of the protection of health under Regulation 12(5) of the Medical Devices Regulations 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 CE 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
How to apply
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 MHRA. Separate applications are required for different patients on a case by case basis.
MHRA will contact the manufacturer or clinician if any information is unclear or if further details are needed. We will usually send the decision to the manufacturer and clinician within 48 hours.
If the application is approved, the decision will also include details of any obligations for the manufacturer and clinician.
Although applications are approved on a case by case basis for each time a device is used, in rare cases, we may consider approval to supply without prior identification of a named patient or to hold an emergency stock for use at short notice. This is especially the case for a device that’s likely to be applied for on multiple occasions.
Published: 18 December 2014