Product Classification and Analysis

Medical devices are divided into four classes. The classification is based broadly, on the risks to which the human body can be exposed due to the design, mode of manufacture or use of the device. The manufacturer should thus perform a risk analysis of the design, method of manufacturing and intended use of the device.

Class I: Registration at the MPA

Class I is comprised of the least dangerous devices and is the largest group. If a manufacturer of class I devices has his registered place of business in Sweden, he or his authorised representative, with a registered place of business in Sweden, shall send notification of the company and the device/s to Swedish Medical Products Agency which will register the company and the devices against an annual fee.

Swedish Medical Products Agency will issue confirmation of registration in the form of a Certificate of Registration which allows the device/s to be placed on the market.

The manufacturer assures that the device/s complies with the essential requirements and compiles a technical file and a declaration of conformity which are to be maintained for at least five years. If the device has a measuring function (class Im) or is placed on the market in a sterile condition (class Is), a Notified Body shall check the manufacturing process to assess whether the measurement function and sterility comply with the essential requirements.

The classification of the devices is carried out by the manufacturer, possibly in cooperation with a Notified Body.

Class IIa: Limited third party assessment is requried

Class IIa requires assessment by a Notified Body (third party assessment) for certain aspects.

The manufacturer may choose between two alternatives:

  1. The manufacturer declares that the device is in conformity with the essential requirements. The Notified Body performs a type-examination of products and/or batches or certifies the quality assurance system for manufacturing and/or final inspection.
  2. The Notified Body certifies the manufacturer´s quality assurance system. Swedish manufacturers or authorised representatives of custom-made devices shall register with the Medical Products Agency.

Class IIb and class III: Third party assessment required


Devices in class IIb and class III have a higher risk potential and shall be assessed by a Notified Body. The manufacturer has two alternatives.

  1. The Notified Body certifies the manufacturer´s entire quality assurance system.
  2. The Notified Body performs a type-examination of the device and/or batches or certifies the quality assurance system for manufacturing and/or final inspection.

It is required for all devices that the assessment is documented in the form of technical files, declarations, explanations, type certificates etc. This documentation shall be written in one of the official languages of the EEA or in a language accepted by the Notified Body in question.

 

 

 
 

Applications

Application for registration of class I devices shall be sent to:

Medical Products Agency
Medical Devices
P.O. Box 26
SE-751 03 UPPSALA

Telephone +46-18-17 46 00
Fax +46-18-50 31 15

   
 

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