Regulatory Focus™ > News Articles > 2019 > 2 > MHRA Clarifies Medical Devices Policies for Users

Regulatory NewsRegulatory News
Posted 11 February 2019 | By Ana Mulero 

MHRA Clarifies Medical Devices Policies for Users

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a new guidance document on Monday to clarify existing policies and procedures around the use of medical devices.

The agency’s guidance provides information that ranges from the definition of a medical device and CE marking to information on buying devices for personal use, as well as problems associated with device use and troubleshooting.

For those interested in buying a medical device for personal use, MHRA outlined four important criteria to consider and four additional important criteria before using the device. These include ensuring that the medical device is suitable for the medical condition and that it is not damaged.

Under problems and troubleshooting, the guidance points to four types of problems that should be reported to MHRA. These relate to whether a device was damaged upon receipt, there is no CE marking on the device, its user manual or packaging, unclear user instructions and lack of manufacturer address.

MHRA directed users to contact the corresponding manufacturer if there is a worry about the quality of the device or if the device breaks down. “These reports could help manufacturers improve their design and product information, and also help the MHRA improve the safety of devices,” the agency noted.

Further, the guidance singles out two types of medical devices that are commonly purchased for personal use. Several safety tips were included for both blood glucose meters and contact lenses.



© 2022 Regulatory Affairs Professionals Society.

Tags: guidance, MHRA, UK

Discover more of what matters to you

No taxonomy
No data found