If you're involved in developing a medical app then you should be considering compliance as part of your overall project as you will need assess if your app is classed as Software as a Medical Device (SaMD). If it is then it will need to be CE Marked. We've created this short presentation to provide you with a quick guide to medical app regulation.

1. Copyright © Genetic Digital 2012
A quick guide to
regulation of
medical apps

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Developing a regulatory strategy
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Failure to obtain the necessary regulatory approvals from the
outset can be catastrophic. It is therefore very wise to invest time
in developing a regulatory strategy, taking into account the
following considerations:
• Take time and (if necessary) obtain advice about which regulatory
frameworks will apply to your app - MHRA, FDA, ABPI, MDR
• Failure to have the necessary approval is often an offence and could also
lead to app store rejection
• Take care to calculate the timeframe required to complete all of your
regulatory approvals, factoring in both the time it takes to complete the
required paperwork and the risk of non-approval
• Applications for regulatory approval generally require individuals to be
nominated to take on certain statutory functions, making them the first
port of call for the relevant regulator
• Review the App Store guidelines for publishing medical apps
• Don’t forget about data protection - HIPAA and GDPR compliance

3. Medical device apps
The MHRA is the UK competent authority
responsible for ensuring that medicines and medical
devices work and are acceptably safe.
In the UK and throughout Europe, mobile apps that
meet the definition of a medical device are required to
be CE marked in line with the EU medical device
directives
This is to ensure they are regulated and safe to use
and also perform in the way the manufacturer intends
them to. Health related apps that are not medical
devices fall outside the scope of the MHRA.
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Is my app a medical device?
Key questions to consider:
• Does the app have a ‘medical purpose’?
– prevention/diagnosis of a disease, injury, disability
– monitoring, treatment or alleviation
– compensation for an injury or disability
– investigation, replacement or modification of anatomy or
physiological process
– control of conception
– prediction, prognosis
• software intended for lifestyle and
well-being purposes is not a medical device
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Medial device apps
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For apps that meet the definition of a medical device, the following
guidance is given to aid some key requirements of CE marking:
• Classification: Manufacturers of medical device apps will need
to determine the classification of their product to determine the
route to compliance.
– There are four classes as follows: Class I; Class IIa; IIb; Class III
• Essential requirements: The software must meet all of the
general essential requirements and the relevant design and
construction essential requirements contained in the medical
device directives.
• Post market surveillance: Once a medical device has been
placed in the UK market, the manufacturer is responsible for
monitoring the product and reporting serious adverse incidents.

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App labelling
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A prospective customer should be able to identify that the app meets the relevant
essential requirements prior to download. The manufacturer should display the
CE mark on a primary landing page and as a screen shot in any app store.

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How can we help you…
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As experts in medical app development we can
help you with:
• mHealth Strategy
• Proof Of Concept Development
• App Prototyping
• UI Design
• Native, hybrid & PWA app coding
• Backend Development & Cloud Storage
• Systems Integration
• App Testing
• Bluetooth/NFC/Wireless Connectivity
• Regulatory Planning & CE Marking
• HIPAA & GDPR Compliance

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Experience & Expertise
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• Knowledge of healthcare audiences & behaviours
• Patient & HCP UI/UX design experts
• Adherence to medical & pharma regulatory
standards (MDD/MDR/FDA/ABPI)
• Design to EN 62304 medical software lifecycle
• Compliance assessments & technical file creation
• Address all security and privacy concerns
• Strong and up-to-date technical skillset
• Comprehensive and robust testing practices
• Cross-platform expertise
• Smart medical device / IoT connectivity
• Built the first CE Marked pharma app

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Medical device apps portfolio
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https://www.geneticapps.co.uk/case-studies/

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The QUiPP app is a clinical tool
used by doctors to help assess
a woman’s risk of preterm
birth. The app looks at different
measures that can affect how
likely it is for a woman to give
birth early:quantitativefetal
fibronectin(fFn), cervical
length, and whether a woman
has previously hada premature
birth.
Working alongside Guy’s &
St.Thomas’Hospitalwe
collaborated on the
developmentof TechnicalFile
for the CE marking application.
The app is registered with the
MHRAas a Class I device
QUiPP Clinical Tool

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OvuSense™ is a unique,
real-time ovulation cycle
monitoring system.
A vaginal sensor (Class IIb
device) collects
temperature readings &
sensor data is sent to the
app predicting their
ovulation cycle.
The product complies with
MHRA and FDA
regulations and is CE
marked and FDA listed.
OvuSense Fertility App

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The Rosemont Pharmaceuticals
App acts as both a product
reference guide and as a liquid
medicinedosagecalculatorfor
useby HCPsonly.
The app met the definitionof a
medicaldeviceand so we took
the app through the CE marking
process by producing the
necessary paperwork and
technicalfilethat was required
to support the app’s application.
This included a process of
clinical validationand
verification.The app is
registered with the MHRAas a
Class I device.
Liquid Medicine Dose Calculator

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Get in touch
Genetic Digital - www.geneticdigital.co.uk/contact/
Genetic Apps - www.geneticapps.co.uk/contact/
Email us:
evolve@geneticdigital.co.uk
Twitter:
@geneticdigital
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