Pharma IT Test Automation Banner

← Back to Insights

Oct. 27, 2020

Software as a Medical Device

Software is increasingly becoming the go-to method for diagnosing illnesses and monitoring health. From a user perspective, this means that it is of the utmost importance that manufacturers live up to existing standards and regulations. From a company perspective, it can create challenges concerning new and updated legislation such as the EU MDR.

With the EU MDR in place by 2021, companies must now increasingly focus on whether their software is also categorized as a Medical Device or not, as well as on what implications being a Medical Device has on the Software Development Life Cycle (SDLC) and subsequent operation of software products.

What is Software as a Medical Device? It’s not a fitness watch!

The EU MDR makes it clear that there is a distinction to be made between software as a medical device and software intended for use for lifestyle or wellbeing-purposes. Software used for the latter is not a Medical Device.

Software as a Medical Device-products, specifically, are designed for medical purposes. Such software products often serve different medical purposes, and are typically related to diagnosis, disease prevention, or treatment of an illness or injury. Additionally, according to the International Medical Device Regulators Forum, Software as a Medical Device is defined as: “. . . software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. This means that, in order for software to be considered as SaMD, the software must not principally drive a hardware device.

Where should a manufacturer begin in order to be EU MDR-compliant?

It is important that a manufacturer, from the earliest phases of product development, considers exactly what, and why, a particular product is put on the market. In order to be compliant with the EU MDR, the manufacturer must be able to describe what the product is going to help people with; in essence, the intended purpose of the product must be clear.

Below are a few considerations that will set you off in the right direction. The list is not exhaustive, but it covers some of the essential cornerstones in EU MDR-compliance:

  • Does the software qualify as a medical device? (MEDDEV 2.1/6 (July 2016)
  • What is the classification of the software? (MDR, Annex VIII, section 6.3. rule 11)
  • Which Standards, Regulations or guidelines are mandatory to comply with? (seek inspiration in i.e. IEC/EN 62304 Medical device software)
  • How are the safety, security, and performance requirements secured? (MDR, Annex I)

Do you want to know more about the EU MDR?

You are welcome to contact us!

← Back to Insights