Swedish Regulators Publish Guidance on Software as a Medical Device

Sweden's medical device market regulator, the Medical Products Agency (MPA), has issued expanded guidance on how the European Commission plans to address software used as medical devices.

The Swedish guidelines follow a revision to Medical Device Directive 2007/47/EC announced in January 2012, MEDDEV 2.1/6, which addressed stand-alone healthcare software falling into the EU's medical device regulatory framework.

After consulting with Swedish medical device industry sources, the Medical Products Agency published the following recommendations to determine whether a stand-alone software product qualifies as a medical device according to a manufacturer's stated purpose for the product:

  • The software should have functionality that supports its intended use
  • The product risk assessment should consider patient safety
  • The manufacturer should demonstrate that product performance meets a medical purpose (via clinical evaluation, for example)
  • The manufacturer should obtain CE Marking for the software

How a manufacturer describes its software product is crucial to determining whether that product qualifies as a medical device under EU law.

"If a manufacturer describes a software product in such a way that it can be regarded as a medical device, it must be CE marked under the medical device regulations," the MPA guidelines state. "A user should then expect the manufacturer to have taken into account patient risk and patient benefit when designing the system. This can be seen in the risk management process and in the post-market follow-up of experience from products in use."

Software systems described only in general administrative or technical terms cannot be considered medical devices, according to the MPA, and end-users cannot assume that any patient risk or benefit factors have been taken into account by the manufacturers.

As MEDDEV 2.1/6 focuses primarily on software manufacturers only, these guidelines are part of a broader MPA project in collaboration with Swedish industry, healthcare providers and the National Board of Health and Welfare to cover additional medical device counterparties in the Swedish healthcare market.

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