• Is your device controlled by software?

  • Concerned about documenting software design, development and validation?

  • Does your software risk analysis support the device safety and performance claims?

  • Does your quality system include appropriate software-related procedures? 

 

 
The word 'software' is not defined by the IVD Directive, but Article 1.2(a) defines a medical device as: “any instrument, apparatus, … including the software necessary for its proper application…”. This definition applies to IVDs because they are a subset of medical devices, so software used to control IVDs falls within the scope if the IVDD.
 
 
For IVDs, there are three principal types of software:
 
 
  • Software as a constituent part of an IVD. This covers software integral to an instrument or apparatus, without which the device would not function or fulfill its intended purpose. Such software is covered by the IVD Directive and validation of the software must be included in the CE marking assessment for the device.

 
 
  • Software as an accessory to an IVD. This is software not included as an integral part of the device, but intended specifically by the manufacturer to be used together with an IVD. Such so called 'stand alone' software, if placed on the market separately from the IVD must be treated as an IVD in its own right, and so will also fall within the scope of the IVDD.

 
 
  • Software not covered by the IVD Directive. This is software that allows result processing, after the generation of correct analytical result(s), for example LIS (Laboratory Information System) software that allows manipulation of results for administrative or statistical purposes.

 
 
GEAMR can provide specialized computer system validation and compliance services to help manufacturers - please contact us for further information.