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.