SaMD (Software as a Medical Device) and Reflecting on EU MDR Compliance 

SaMD (Software as a Medical Device) and Reflecting on EU MDR Compliance 

Diagnosing illnesses and monitoring health is increasingly reliant on utilizing software. For patients, manufacturers must maintain standards and regulations. Companies can be concerned with challenges concerning updated legislation such as the EU’s MDR. 

Companies have increased importance on determining whether their software is categorized as a medical device, as well as implications that being categorized as such has on the Software Development Life Cycle (SDLC) and further use of software products now that the EU MDR is in place. 

Explaining Software as a Medical Device 

The EU MDR creates a clear distinction between Software as a Medical Device and software created to enhance lifestyle and wellbeing. 

Software as a Medical Device products are explicitly designed for medical purposes relating to the diagnosis, prevention or treatment of an illness, injury or disease. 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.” Software must not drive a hardware device in order for it to be classified as SaMD. 

How Can Manufacturers be Compliant with EU MDR? 

Manufacturers should consider the reasons why their particular product is placed on the market. In order to maintain compliance, manufacturers need to clearly describe the intended use of the product.  

Here are a few essential considerations around EU MDR compliance: 

  • Does the software qualify as a medical device? (MDCG 2019-11) 
  • How is the software classified? (MDR, Annex VIII, section 6.3. rule 11) 
  • Mandatory guidelines, regulations and standards. (seek inspiration in i.e. IEC/EN 62304 Medical device software) 
  • How the safety, security, and performance requirements are secured. (MDR, Annex I) 

Contact PharmaIT to learn more about EU MDR compliance and SaMD. 

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