We like to make our webinars interactive and after our recent webinar on ‘EU MDR’s Impact on Labeling: UDI in Europe and Other Changes’, I thought it would be great to highlight the top five facts we saw strong responses to (if you’re interested in seeing the webinar you can access the video HERE).
So, what did we see as the top 5 facts? Here are my observations...
#1 - Labeling is a mission-critical part of the business for medical device companies - a complex web of multiple organizational touch points across a diverse end-to-end process. And it’s widely accepted that the new EU regulation will have major implications on labeling operations for every manufacturer. Many companies will need to rethink both their label designs and the systems as every single label being produced will need to be changed. Gone are the days of batch labeling - a new world has arisen where individual products need to be married with the right label at the right time. It requires a data-led label lifecycle management to ensure critical data from across the globe is glued together whenever and wherever it’s required.
#2 – The ‘Real Estate’ of labels has become even more precious with the introduction of EU MDR. With the new regulations comes new elements of what must be on your label including warnings, additional serial numbers and lot numbers, and for many smaller devices, this leaves little space to juggle essential elements – it’ both a data and design challenge. It will force organizations to design new label templates that make room for data not previously part of the labeling system.
#3 - Non-supported operating systems and databases of certain Microsoft and Oracle products is now a reality for many medical device companies by 2020. Organizations need to select a labeling solution that can adapt to a changing world.
#4 – eIFUs can now be implemented as part of the new EU regulations. IFU’s (Instructions for Use) may be provided to the user in a non-paper format - i.e. electronic – if the manufacturer clearly indicates on the packaging of each unit or the device itself that the instructions for use of the device are supplied in electronic form under 207/2012 Article 6.1. Manufacturers must also provide information on how to access the instruction for use in electronic form.
#5 - Cost of label change is inevitable. Companies from our customer base experience a cost between $2 mil and $6 mil. There was always going to be a knock-on cost for companies to implement the new EU MDR regulations. However, what many companies hadn’t predicted was the non-supported operating systems and databases hitting within a similar timeframe. And so many companies are looking at a ‘touch once’ approach – implementing compliant labeling solutions now before the deadlines of operating systems and scheduled label system upgrades timeline, so that there’s not a double cost.
We had a huge amount of feedback on this particular webinar with nearly 900 registrations! If you haven’t watched the recording of the webinar yet, you might like to see what one attendee had to say...
"This webinar presentation of EU MDR was the best I have experienced. Better than many conferences and other webinars that we participated in over the last 10 to 12 months.”
Finally, to help you on your journey to successfully adopting the new EU MDR regulations, we’ve put together an infographic with a sample of a Medical Device Label before and after EU MDR.
We hope some of these insights will be useful to you but, of course, please let us know if you have any other related questions.
About the author
Mark Cusworth, VP Research and Development, PRISYM ID
Mark has over 15 years of experience heading up a team providing off the shelf and tailored solutions to Life Science companies. During this time, he has seen many changes to the industry including significant tightening of regulations and challenges of globalization. His primary objectives are to target the ongoing investment in research, development and quality effectively and to lead the company in-house research and development.