Medical devices

Since 2001, the Swedish Medical Products Agency assumes the responsibility for market surveillance related to the law on medical devices and issuing directives with the support of this legislation.

The overriding goal is that medical devices shall be suitable for their intended purposes, which means that they must be safe and display the properties stated by the manufacturer.

What is a medical device?

The term medical devices covers a very broad area of products intended for use within all areas of health and medical care. The range covers simple items such as plasters to large, advanced systems such as computerised tomography scanners as well as active implants such as pacemakers. The category also includes aids for the handicapped, dental products, implantable products, birth control products plus all reagents, test systems/technologies and instruments within laboratory medicine (so-called in vitro diagnostics). In addition, a new product range now being introduced onto the world market is modified human tissue.

Quality

To ensure maintained quality, every product released onto the market must fulfil the demands required. Responsibility lies with the manufacturer. In addition to safety and performance, adverse effects and risks also need to be described. Instructions for use and all labels must be in Swedish whether the product is to be used by the patient or by qualified personnel.

Third party assessment

For certain products, even the manufacturer’s internal checks are not sufficient. Here, a third party, a so-called Notified Body, assesses the product. In Sweden, these bodies are accredited by the Swedish Board for Accreditation and Conformity Assessment (SWEDAC). Supervisory responsibility includes control of the company’s handling of product safety, following up accidents and incidents involving medical devices, inspections of manufacturers plus evaluating clinical trials planned within the area.

 
 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information