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A quick guide to regulation of medical apps


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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.

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A quick guide to regulation of medical apps

  1. 1. Copyright © Genetic Digital 2012 A quick guide to regulation of medical apps
  2. 2. EVOLVE YOUR DIGITAL DNA Developing a regulatory strategy 2 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. 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. 3 EVOLVE YOUR DIGITAL DNA
  4. 4. EVOLVE YOUR DIGITAL DNA 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 4
  5. 5. EVOLVE YOUR DIGITAL DNA Medial device apps 5 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.
  6. 6. EVOLVE YOUR DIGITAL DNA App labelling 6 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.
  7. 7. EVOLVE YOUR DIGITAL DNA How can we help you… 7 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
  8. 8. EVOLVE YOUR DIGITAL DNA Experience & Expertise 8 • 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
  9. 9. EVOLVE YOUR DIGITAL DNA Medical device apps portfolio 9
  10. 10. EVOLVE YOUR DIGITAL DNA 10 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
  11. 11. EVOLVE YOUR DIGITAL DNA 11 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
  12. 12. EVOLVE YOUR DIGITAL DNA 12 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
  13. 13. EVOLVE YOUR DIGITAL DNA Get in touch Genetic Digital - Genetic Apps - Email us: Twitter: @geneticdigital 13