EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746) went into effect in May 2021, after about a year’s delay due to COVID-19. Medical device manufacturers have known about the new regulations for years and have been working to meet these new, more stringent standards.
I recently co-presented a webinar with one of my technology partners, RWS, about the MDR and its impact on medical device content. We discussed how structured content can help medical device manufacturers meet the new requirements. We also spoke about other content challenges that can be addressed by having a structured content ecosystem and a solid content strategy to guide it.
I’ve summarized my presentation into six key challenges and solutions:
Time to Market
Medical device manufacturers are always under pressure to get their projects to the market as soon as possible. There are many content requirements for these devices. Medical device manufacturers need to speed up the time it takes to create, translate, review, and approve the content.
Similar but Different Requirements
Health authorities around the world often have similar requirements. However, the order, format, and templates used can vary widely. Using standardized, structured content sets medical device manufacturers up for maximum reuse.
Move to Onboard and App-Based Content
Device manufacturers are moving to more app-based and onboard content. While long-form, printable content is still produced, more and more of the content needs to be chunked for small screens on devices and in companion apps.
Reuse without Content Drift
Medical device content has a lot of reuse potential. In order to keep a single source of truth and avoid content drift, manufacturers need to reference small, format-free, reusable pieces, rather than copy / paste / tweak.
Start from What’s Already Been Approved
It is always best to start off with previously approved content. Regulators are more likely to accept language that they approved in a previous submission (though it’s not guaranteed).
Devices are Getting Smarter
Medical devices are getting smarter. The industry must move to standardized, structured content to accommodate the advances that are coming.
If you’d like to watch the whole webinar, it’s available on-demand on BrightTALK: Embracing Medical Device Regulations with Structured Content.