The 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.
Medical devices have assumed ever-greater importance in care and welfare and often play a decisive role for diagnosis and treatment. In September 2001, the Medical Products Agency assumed 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.
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.
To ensure maintained quality, every product released onto the market must fulfil the demands required of current legislation. Responsibility lies with the manufacturer who, in the majority of cases, carries out internal checks to ensure that products meet their requirements. 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 irrespective of whether the product is to be used by the patient or by qualified personnel.