Following our recent webinar in partnership with KPMG titled ‘The Clock is Reset…Opportunity for your Organization to Re-Evaluate Compliance to EU MDR Labeling,’ we’ve picked out five key learnings that will aid better understanding of EU MDR labeling following the year extension to regulation implementation. If you wish to watch the webinar in full, follow the link here.
Here are five key points:
- The deadline for EU MDR has been extended for a year – EU MDR regulation effectively shifts from May 2020 to May 2021. This will give Medical Device manufacturers that were not able to comply in 2020 the chance to get their processes in order before the 2021 deadline. Companies using a notified body in the UK must still change their labeling by the end of the transitional period, December 31, 2020.
- Perform a gap assessment of your entire labeling processes – it is important to begin a gap assessment as soon as possible to ensure compliance with EU MDR. The five key areas to look at are resources/budget, processes, labeling systems, requirements strategy and implementation area. With further frequency and volumes of changes on the horizon, now is the time to try and future proof your labeling processes. If EU MDR compliance has not already been achieved, these projects should be the number one priority for medical device manufactures this year.
- Product data in silos across multiple systems generates high level of risk – it is crucial that medical device manufacturers understand the role data plays within their labeling processes. The objective of Article 23.1 is to increase the transparency of data to end users to ensure patient awareness and safety. Every medical device should be accompanied by information to identify the device and the manufacturer as well as safety and performance information relevant to the user. This information may appear on the following: the device itself, the packaging, the IFU (Instruction for Use) and the manufacturer website. Having data in a central system allows for accurate information across all areas.
- Establish a single source of truth – this will allow data to be stored in one place and not across different platforms and processes. If you are using numerous systems for your labeling process, there is a much higher risk of data duplication, inconsistencies, and costly human error. Having a single source of truth will allow for much better traceability across your labeling process and will in turn improve auditability.
- Use ISO symbols as much as possible – the use of ISO symbols is advised for the following reasons. It reduces text on a label, it removes the need for translations, and it will create more space on the label. Under EU MDR, text on a label is required to be translated to the language of the member state where product is sold. Removing the need for translations is very important as many languages are different sizes for example German is around 30% larger than English, so using ISO symbols will help to maximize space on the label.
We hope these five key learnings were useful for you, but if you would like some more information on EU MDR labeling, please don’t hesitate to contact us.
About the author
Jack Cowmeadow, Senior Marketing Executive, PRISYM ID
I’m Jack Cowmeadow, and as part of the marketing team here at PRISYM ID, I have a keen interest in researching and analyzing the key facts, figures and market trends within life science, pharma and medical device labeling. While this research is valuable to my everyday work, it’s great to share this information as part of our blog.