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Standalone Software & Apps as a Medical Device – Guidance

Whether standalone software is a medical device or not is a constant question

 

Are standalone software and apps considered as medical devices?

The exact regulatory status of medical device software has been a vexed issue for several years now. 

And it's an issue that's frequently discussed with Notified Bodies and Certification Bodies in relation to ISO 13485 Certification. Questions of whether standalone software is a medical device or not, or whether an App was a disseminator of information or, in fact, a medical device, are typical.

What UK's MHRA Says About Standalone Software and Apps

The UKs MHRA has published a very useful guide, ‘Medical device stand-alone software including apps (including IVDMDs)’ that clarifies matters.  This guidance is intended to be used in addition to MEDDEV 2.1/6 and is the UK’s interpretation of the guidance.

Note that in the UK and throughout Europe, standalone software and apps that meet the definition of a medical device are required by regulations to be CE marked.

In ISO 13485 implementation you'll need to address this very early on in the process.  It may help you decide whether the services of a Notified Body (dearer) are required or whether a Certification Body (cheaper) can fulfill your needs. While what's given here is valid for the UK Regulatory Area on the date of publication, you'll also need to monitor the MHRA website to identify revised regulations and the adoption of the UKCA Marking.

The flowchart below, taken from the Guidelines, shows how easy it is to follow the guidance.

Flowchart on How to Determine if Software Can be Considered "Software as a Medical Device"

 

MedDev Software

 

Further Reading

See Medical devices: software applications for the detailed guidelines or head on to our ISO 13485 course overview page to learn more about our ISO 13485 Auditor Training Courses.

 

 

Choose an ISO 13485 Course

 

Note: First published in June 2018; revised and updated in Aug 2021.

 

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deGRANDSON Global is an ISO Certified Educational Organization

InISO 21001 ISO 29993 ISO 29994 October 2021 we secured certification to three education-related ISO Standards.  We now have a university-grade management system in place conforming to the requirements of  …

  • ISO 21001, Educational Organizational Management System,
  • ISO 29993, Learning Services outside formal Education,  and
  • ISO 29994, Learning Services – additional requirements for Distance Learning.

We have chosen ISO 21001 certification because, unlike IRCA and Exemplar badges (which in our opinion are commercially compromised), it is based on independent third-party assessment.  It is a ‘university grade’ standard in use globally by schools, colleges, and universities to demonstrate their competence.

 

Written by Dr John FitzGerald

Director & Founder of deGRANDSON Global. Spent 15 years in the manufacturing industry and 25 years training, consulting & auditing management systems
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