Supervision of medical devices – priorities, implementation and follow-up

The overall conclusion is that government agencies’ conditions need to be strengthened if supervision is to become more effective. Supervision of medical devices has been limited in relation to the size of the market and the scope of medical devices used – and manufactured in-house – in the healthcare sector. Supervision has often had to give way to other tasks that the government agencies have had to deal with. In the case of the Medical Products Agency, these other tasks have been related to the implementation of EU regulations and government assignments. In the case of the Health and Social Care Inspectorate, the agency’s areas of supervision are extensive, and medical device supervision accounts for a small proportion of its total supervisory activities. The Health and Social Care Inspectorate has not identified the use and in-house manufacture of medical devices as priority areas for supervision, in relation to other areas that have been deemed to pose higher risks to patient safety.

It is the assessment of the Swedish National Audit Office that the Medical Products Agency’s supervision of economic operators and medical devices on the market is largely organised in an effective manner to ensure that products are safe and suitable for use, and to counteract unfair competition. However, some conditions for supervision are inadequate. This includes problems with the agency’s case management system, which causes efficiency problems. The Medical Products Agency’s current model for annual fees for economic operators also creates challenges both for the agency’s planning and for medical device companies, where high annual fees have had negative consequences for small companies. The audit also shows that the Medical Products Agency has not sufficiently shared its supervisory results with the medical device industry and the healthcare sector.

Furthermore, it is the assessment of the Swedish National Audit Office that the Health and Social Care Inspectorate’s supervision of medical devices and medical devices manufactured in-house has not been organised and implemented in a sufficiently effective manner. During parts of the audited period, 2020–2023, the Health and Social Care Inspectorate has lacked expertise in the field of medical technology, partly due to vacancies. The audit also shows that the Health and Social Care Inspectorate has lacked internal support for supervision, such as written support for risk assessment and risk analysis. In addition, the agency’s register of in-house manufacture of medical devices does not include information specifying which products are manufactured by healthcare providers. This means that the agency has not had a full overview of the products that the agency is responsible for supervising. The Swedish National Audit Office considers that the Health and Social Care Inspectorate should develop its expertise in the field to enable it to take better account of issues concerning the use of medical devices in the agency’s supervision, where relevant.

The Swedish National Audit Office considers that the Government should follow up the government agencies’ conditions and work to ensure that they contribute to effective supervision. The audit shows that the Government needs to review whether the supervision of medical devices manufactured in-house should be transferred from the Health and Social Care Inspectorate to the Medical Products Agency, which has the overall responsibility for medical device supervision. The audit also indicates that there is a considerable need for information and support related to the regulatory framework for medical devices, both among companies and in the healthcare sector. Therefore, the Government should instruct appropriate agencies to disseminate information and knowledge support to relevant actors.