How we regulate devices

All Medical devices that are placed on the market in the UK have to comply with two sets of device-specific legislation:

  • European Union laws – the Medical Devices Directives and Regulations
  • UK laws – the Medical Devices Regulations

Each member state of the EU implements the Directives into their own national law; in the UK these are the Medical Devices Regulations 2002 (as amended) and they are issued under the Consumer Protection Act 1987. EU regulations apply directly to the UK and do not need to be transposed.

The legislation places obligations on manufacturers to ensure that their devices are safe and fit for their intended purpose before they are CE marked and placed on the market in any EU member state.

In this section we provide guidance on the various aspects of regulating medical devices from decisions on whether a product is considered to be a medical device to post-market surveillance of any problems arising from using the device.

Our guidance is intended as a general explanation of the legislation and should not be regarded as an authoritative statement of the law nor as having any legal consequence. It follows that manufacturers and others should not rely solely on this guidance but should consult the legislation referred to and make their own decisions on matters affecting them in conjunction with their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions or other statements in the guidance whether negligent or otherwise. An authoritative statement could be given only by the courts.


Borderlines

The most frequent borderline for products is that between medical devices and medicinal products.
The unwanted display of the text is removed here...dont delete this

Clinical trials

This page provides guidance on how to notify the MHRA of proposed clinical investigations involving non-CE marked medical devices.
The unwanted display of the text is removed here...dont delete this

Legislation

This section provides links to details of the legislation relating to the manufacture, sale and supply of medical devices.
The unwanted display of the text is removed here...dont delete this

Notified bodies

Medium and high risk devices require the use of a notified body to carry out a compliance assessment before manufacturers can place their products on the market.
The unwanted display of the text is removed here...dont delete this

Classification

Medical devices may be classified as Class I,  IIa, IIb or III, with Class III covering the highest risk products.

Enforcement and surveillance

Information on how we ensure that medical devices placed on the UK market are compliant with the legislation.

Meeting the requirements

This page provides guidance on complying with legislation related to medical devices.

Registration of medical devices

This page provides information on the registration of medical devices.
Page last modified: 20 August 2013