How we regulate

Welcome to the How we regulate section.

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.

Further information on how we regulate medicines and medical devices is available in our publication:
› 'Medicines & Medical Devices Regulation: What you need to know'

How we make regulatory decisions about medicines and medical devices
The MHRA and other related organisations make a lot of regulatory decisions. After consulting with a range of stakeholders we have set out on five pages the main considerations that affect those decisions:

• the role of MHRA and the scope of the document
• the main regulatory decisions that are made about medicines and medical devices
• the principles that inform these decisions
• the questions that are considered to ensure that the decisions are reasonable
• who makes decisions about medicines and medical devices – which includes bodies other than MHRA.

A download version of the document is also available:
› Making Regulatory Decisions about Medicines and Medical Devices