Use

Most medical devices are intended for use by healthcare providers. Some medical devices are used in home care or by patients themselves. In addition, many medical devices are intended to be used by users and general consumers and can be purchased from retailers (shops, pharmacies) and from online retailers.

New regulations under way

The medical device field is currently undergoing an extensive transformation as a result of the old legislation with European directives and the Medical Products Agency's regulations gradually being replaced by European regulations. The change means that common legislation is retained, but increased and clearer demands are placed on manufacturers in order for users to have access to safe and effective products. Additionally, importers and distributors are covered by the new legislation. There are also increased demands placed on the reviewing body (known as the notified body) and medical device authorities.

The new regulations will come into effect as of:

• 26 May 2021 for general medical devices (MDR 745/2017)
• 26 May 2022 for in vitro diagnostic (IVD) medical devices (IVDR 746/2017).

The changes apply to devices that manufacturers place on the market from 26 May 2021 and 26 May 2022, respectively.

Medical devices that have been manufactured and placed on the market before these dates, and which are used in healthcare or by other users, may continue to be used as usual over the lifetime that the manufacturer has defined for the devices.

Characteristics of a legal device

In order to check whether a device is a legal medical device, you can look for the following:

• the device has labelling in Swedish that includes information on the device’s name, intended use, the manufacturer’s name and address (physical address)
• the device has a CE mark
• the device has instructions for use and they are in Swedish. Some very simple devices which can be used safely without instructions for use may not have them. Consumer devices must also have instructions for use
• the device has a UDI label for identification and tracking. Some devices may lack this during a transition period (transition from the Medical Products Agency’s regulations to European regulations).

When buying devices for use in healthcare, for example at procurement, additional information may be helpful or needed. It may, for example, be the case that demands are placed on the manufacturer to produce:

• an EU declaration of conformity
• proof of registration if it concerns a device that must be registered with an authority
• certificate from a notified body when it concerns a device with higher risk potential (higher risk classification).

Responsibility of the authority

The Medical Products Agency is the authority that is responsible for monitoring medical devices placed on the Swedish market and their manufacturers and, in accordance with the new MDR and IVDR regulations, for other economic operators such as importers and distributors. The Medical Products Agency cooperates closely with other medical device authorities within the EU. The Health and Social Care Inspectorate (IVO) in Sweden is responsible for monitoring healthcare, the use of medical devices and devices that are manufactured within healthcare institutions, known as in‍-‍house manufacture.