Get access to PAGB’s codes of practice for advertising OTC medicines and medical devices to consumers and professionals, as well as guidance on specific types of advertising to keep your campaigns compliant.
Categories: self care medical devices, digital, advertising, regulatory
Access: PAGB members and associate members only. Not a member of PAGB? Find out more about membership or our regulatory consultancy services here
Are you clear on when an app should qualify as a medical device? And do you know what regulatory requirements you need to comply with?
This guidance is intended to support companies producing software applications related to consumer healthcare products.
- Regulatory requirements for software medical devices
- Considerations when launching apps
- Advice on optimising your Appstore listing
We provide examples of healthcare apps already on the market and signpost you to the relevant guidance to follow for GB, NI and EU, including what mark to affix in different territories.
It is particularly relevant to regulatory professionals but will also be of interest to anyone involved in developing software applications.
It does not cover software applications that could qualify as in-vitro diagnostic medical devices.
This guidance has been developed by PAGB and for PAGB member companies and partners and is not intended as legal or regulatory advice. It should be read alongside the relevant PAGB Codes of Practice and current regulatory, legal, ethical, and national government policy documents, to ensure that up to date guidance and regulations are followed. All software applications must comply with relevant regulations.
For regulatory advice, contact email@example.com
All advertising and marketing materials must still comply with all relevant regulatory requirements including those set out in the MHRA’s Blue Guide, PAGB Advertising Codes for Medicines, PAGB Medical Devices Consumer Code (MDCC), CAP guidance and current requirements for adverse event reporting.
Not a member of PAGB? Find out more about membership or our regulatory consultancy services here
PAGB’s Codes of Advertising Practice, guidelines and additional guidance are available here. Log in to the members’ area to access the full range of guidance. For more information, contact firstname.lastname@example.org.
Published July 2021
For more information about this guidance, please contact email@example.com