MHRA provided advice for manufacturers, members of the public and professional users of software or apps being used during the COVID-19 pandemic.
Standalone software and apps that meet the definition of a medical device are required to be CE marked in order to demonstrate that they are acceptably safe to use and perform in the way the manufacturer/developer intends them to.
The following types of software are likely to be classed as medical devices:
- software (including artificial intelligence) and apps (either incorporated into an existing device or supplied separately) that are used for contributing to diagnostic processes
- software and apps for helping patients to manage their health conditions like diabetes, cancer or mental health issues
- software and apps for monitoring patients (including remotely)
- software and apps to support clinical decision making
MHRA previously published specific software guidance on medical device stand-alone software including apps.
For more details, please see the original guidance from MHRA.
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US.
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This article provides general information and does not constitute regulatory, legal, clinical, or compliance advice. Requirements and appropriate processes may vary by study, product, jurisdiction, and organization. Medigen Suite functionality should be used in accordance with applicable regulations, study documentation, and internal procedures.
