Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the effect of the regulation of section 6 of the Health and Safety at Work Act 1974 on medical devices containing computers.

The Department has not made any assessment of the effect of the regulation of section 6 of the Health and Safety at Work Act 1974 on medical devices containing computers.

Section 6 of the Health and Safety at Work Act 1974 places duties on any person who designs, manufacturers, imports or supplies any article for use at work to ensure that it will be safe and without risks to health. In general this applies to all devices used in the workplace but there are exceptions, such as medical devices, which are regulated by specific regulations that set out more detailed duties.

The Medical Devices Regulations 2002 deal with the design, manufacture, import or supply of medical devices, including those which may contain computers/software. It is for the designer, manufacturer, importer or supplier to demonstrate that their product is safe. These regulations transpose the requirements of the following European Directives concerning product safety for medical devices:

- Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD)(1990);

- Council Directive 93/42/EEC on Medical Devices (MDD)(1993); and

- Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD)(1998).

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the United Kingdom. The following link provides more information on MHRA and its role:

https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety