CQC Compliance Quality Assurance
Care & Client Management

The MHRA is an Executive Agency of the Department of Health, with the function of enhancing and safeguarding the health of the public ensuring that medicines and medical devices work and are acceptably safe.

The MHRA web site says that:

The MHRA regulates a wide range of materials from medicines and medical devices to blood and therapeutic products/services that are derived from tissue engineering. This section helps describe how the MHRA manages each of these products, including the use of nanotechnology in some of them.

The main difference between how medicines and medical devices are regulated lies in how a product gets onto the market. All medicines are directly approved by the MHRA which issues a ‘marketing authorisation’, or licence. Manufacturers and distributors are also licensed directly by MHRA. Medical devices are approved by private sector organisations called 'Notified bodies'. Their approval is needed before a CE mark can be put on the device, though the manufacture of low risk devices is simply registered with the MHRA. The MHRA audits the performance of Notified Bodies. However:

• when a product is on the market and in use, there are more similarities than differences in the ways medicines and devices are regulated
• there are similar systems for receiving reports of problems with products and similar ways of issuing warnings if problems are confirmed after investigation
• there are also similar systems for inspection of manufacture to ensure that companies are complying with regulations, and similar ways of enforcing the law if that proves necessary.