Manufacture of medical devices

Two regulations set out the key requirements that manufacturers must meet:

• Regulation (EU) 2017/745 on medical devices (commonly referred to as the ‘MDR’)
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices (commonly referred to as the ‘IVDR’).

Medical devices constitute an important basis for good and safe healthcare. They are used by healthcare providers, by patients themselves and not least by consumers.

Specific demands are placed on manufacturers to take into consideration the needs and levels of knowledge of different user groups already during the device development phase.

Qualification and classification

Manufacturers must determine at a very early stage during the development of a device whether or not the device is a medical device; this is known as ‘qualification’. Classification of the device from the perspective of risk is another decision that the manufacturer must make at an early stage of device development, as the risk class of the device determines what type of procedure the manufacturer must follow in order to get its device CE marked.

More information about qualification:

The Swedish Medical Products Agency’s responsibilities

The Swedish Medical Products Agency's (Swedish MPA) goal is for users of medical devices to have access to safe devices that are suitable for their intended use.

The Swedish MPA task is to carry out monitoring to ensure that relevant legislation in the medical device field is complied with. This monitoring will continue to take place via market surveillance through, inter alia:

• follow-up of incidents and serious incidents (MDR)
• follow-up of adverse events and serious adverse events (IVDR)
• supervisory activities aimed at manufacturers and other economic operators

The Medical Products Agency is responsible for reviewing planned clinical trials. The agency also conducts ongoing oversight of the designated notified bodies based in Sweden to ensure they are performing effectively and are retaining the necessary competence to undertake their designated activities.

Other authorities

The National Board of Health and Welfare is responsible for:

• regulations on the use of medical devices in healthcare
• regulations on in-house medical devices.

The Health and Social Care Inspectorate (IVO) supervises:

• how medical devices are used in healthcare and in-house manufacture of medical devices.

A medical device is defined in legislation as:

An instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following devices are also to be considered as medical devices:

• devices intended for control or support of conception.
• devices specifically intended for cleaning, disinfecting or sterilising the devices referred to in Article 1(4) and those referred to in the first subparagraph of this point.