The Medicines and Health products Regulatory Agency (MHRA) are responsible for ensuring that medical devices placed on the United Kingdom market meet the appropriate levels of safety and quality.
In order to do so they must meet the relevant essential requirements of the appropriate directive. One way to achieve this is for the device to meet the requirements of the relevant mandated European standard, where one exists. However, the use of standards is voluntary and a manufacturer can if he so wishes demonstrate compliance with the essential requirements by adopting other technical solutions.
Funding for devices work is provided in line with a service level agreement made between the MHRA and the Department. The participation in standards development, at either UK or international level, is not included in the 2006-07 agreement.