The Medicines and Healthcare products Regulatory Agency (MHRA) Medical Devices Division became a signatory to the Work-related Deaths Protocol for England and Wales (WRDP) from 1 April 2012.
MHRA is an executive agency of the Department of Health with responsibility for ensuring that medicines and medical devices are effective and acceptably safe. MHRA’s principal aim is to safeguard public health. The MHRA’s Medical Devices Division has a role in investigating fatal and non-fatal accidents. It has powers under the various Medical Device Regulations, which implement the European Medical Devices Directives, to have products removed from the market and to prosecute manufacturers that place non-compliant or unsafe devices on the market.
By becoming a signatory to the WRDP, MHRA’s Medical Devices Division has now formally agreed to follow the principles for liaison set out in the WRDP when investigating work-related fatal incidents.
This addendum does not include the MHRA Medicines Division, which has not become a signatory. It should be read in conjunction with the WRDP, other Supporting guidance and MHRA/HSE Working Arrangements Agreement.