With the EU confirming the postponement of EU MDR to May 26th 2021, the medical device industry has time to get its house in order. Industry best practice suggests that, to be compliant with the new regulations (as well as highly efficient and productive), labeling strategies – and the solutions that underpin them – must accommodate the following core elements:
Language /Phrase Translation
EU MDR mandates that some of the information printed on all labels needs to be in the appropriate language for the country to which a product is being shipped. Managing language and translations is a complex task, with many organizations struggling to find reliable ways of approving and locking down local language data. However, getting it wrong can be costly. Industry best practice relies on software that includes language and phrase management tools that can deliver country-specific requirements on a global scale. The most effective solutions support multi-language labels and allow the language and phrases printed to be determined automatically based on country data in real time.
The labeling requirements set out in EU MDR are dictated by the type and classification of the medical device being dispatched. This naturally influences label/IFU design and calls for agility and flexibility in labeling solutions. Leaders use tools that allow customisation of label formats as well as multi-page document templates for use with variable, dynamic data. These tools typically provide support for a diverse range of content type – such as rich text, images, barcode, symbols and multi-language phrases – and use intuitive interfaces that enable designs to be built simply and quickly.
Making mass changes to labels can not only be expensive, it can create costly delays in the supply chain. Best practice optimises automation to streamline the process, reducing the cost of making a change by as much as 90% – and also reducing risk. Mass change tools allow companies to identify elements that need to be changed at the push of a button and accelerate revisions all the way to the production line.
Approval workflow processes are one of the biggest causes of inefficiency and costly delay. However, these processes can, through web services, be integrated with your PLM or SAP system to unlock visibility, accelerate workflow and automate global change requirements. Leaders are using tools that allow them to define the rules, steps and groups through which approval requests are routed – and to establish approval workflow templates with robust version control.
EU MDR stipulates that all labels must be checked for accuracy and error. This is a huge challenge but getting it wrong can be costly. Organizations need to ensure that their systems and processes mitigate risk and assure regulatory compliance. Best practice relies on label management software that provides end-to-end label print inspection, as well as management and audit capabilities. The best solutions bring control, operation and visibility under one umbrella – and integrate with inspection hardware that offers high accuracy print verification.
The regulatory landscape is both complex and global. Whilst recent focus has been on high-profile areas like EU MDR and UDI, regulation in regions outside of the US and EU are evolving too – and organizations need to understand and respond to their every nuance. With regulatory agencies all over the world demanding lifestyle traceability of every product, accurate labeling is vital. Progressive organizations have recognised the importance of labeling software that’s underpinned by a ‘regulatory rules engine’ that not only allows them to define specific country requirements, but also gives them operational visibility and control to ensure they comply with them.
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About the author
Richard Castle, Global Account Manager Medical Device, PRISYM ID
Having spent most of his career working within the print sector and enterprise level labeling software, Richard is always keen to learn about the regulatory labeling changes the industry faces, like EU MDR, and share his gained knowledge.
Richard is aware of the complex selection process for labeling solutions that customers experience, and he has a proven ability to align their requirements to solutions that are not only valid for today but aligned to any future impact of regulatory changes.