Guidance for qualification and classification of Medical Information Systems

Thursday, January 31, 2013

Standalone software with a medical purpose has a central role in health care. Depending on the application, they may be subject to the requirements of the medical device regulation. MPA has developed a guide for standalone software with medical purposes in support of manufacturers, health care providers and government agencies.

The guidance includes clarification on the interpretation of existing EU directives and is important as the application of the regulation may differ between European member states.

The purpose of the guideline is to:

  • Clarify the relevant criteria for qualification of standalone software that is a medical device, and the application of classification criteria for such software.
  • Help manufacturers, health care providers and other interested parties to better understand what determines standalone software as a medical device.
  • Clarify the Medical Products Agency’s expectations on the manufacturers.
  • Harmonise the interpretation of the regulatory requirements for standalone software.

The guidance is based entirely on the medical device directives, contains clarifications and interpretations, but adds no further requirements. It is also synchronized with the guidance MEDDEV 2.1/6 to avoid conflicting interpretations.

“We believe the guidance can be an important support for both manufacturers and health care providers”, says Senior Expert Mats Ohlson. “When a system is subject to the regulation for medical devices, the manufacturer’s responsibility and the requirements on the system’s safety and functionality become clear and evident for the parties concerned.”

The guidance reflects many of the issues that have come to the knowledge at the MPA in recent years. The guide also presents product examples for more than 20 medical information systems. It is important to emphasize that patient safety in standalone software depends on a consensus between manufacturers and health care providers, particularly in relation to procurement.


Please note the news item’s date of publishing. The Swedish Medical Products Agency does not update news.


Related information


Contact us

Mats Ohlson
Senior expert
+46 18 17 49 56


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