How medical device companies can prepare for new compliance
Medical device manufacturers are coming under increasing pressure ahead of a wave of regulations coming into force over the next few years. These include the EU’s Medical Device Regulation (MDR); the US Food and Drug Administration (FDA) Class I; and the in vitro diagnostic regulation (IVDR) which comes into effect in May 2022.
Even after that, there are other application dates in multiple different countries on the horizon. The message is clear: now is the time to take a standardised approach to unique device identification (UDI) compliance, and select a process that can be scaled to cover upcoming regulations. Labelling will be a big part of that process.
What EU MDR means for labelling
For many medical device manufacturers, the immediate focus is the EU MDR, scheduled to apply from May 2021. Any medical device manufacturer shipping products to the EU will need to comply with MDR.
Even organisations that have had to comply with previous device directives, will notice the new regulations introduce significant changes which impact labelling. For example, labels need to be in a human-readable format, which manufacturers can supplement with machine-readable information, such as RFID or bar codes. Labels must be legible, according to the user’s technical knowledge, experience and training. There are also specific requirements for sterile barrier labelling, absorbed materials and warnings related to harmful substances.
Meeting these requirements will likely require a complete redesign of a business’s existing labels. In tackling this challenge, manufacturers should look beyond the regulation and uncover the hidden costs and problems in their existing workflow.
Quality and validation
In the context of EU MDR, one of the key areas is quality control. Manufacturers should be encouraged to digitise quality assurance by incorporating review and approval workflows into their label management system. This will provide improved accuracy, transparency and efficiency. Their label management system also needs to enable them to lock down UDI information to reduce the likelihood of errors.
Organisations also need to consider how they will handle and approve mass label changes. Instead of manually creating thousands of label designs for each SKU that then need to be approved, they need to implement a labelling system that can automate mass label changes and approvals.
One of the critical tasks before going live is completing system validation. Here it can help to use a validation tool that aligns with regulatory requirements, which can simplify compliance with industry standards and make it easier for them to maintain a validated, compliant labeling solution. They need to be aware that by standardising on a single labelling platform with a digitised quality workflow, they only have to validate one system, as opposed to individually validating multiple, disconnected modules.
How cloud-based labelling helps
Once they have created an MDR-compliant labeling process, manufacturers will want to ensure their labels stay compliant, no matter who prints them. Manufacturers need to consider granting their suppliers and contract manufacturers remote access to their labelling system using cloud technology.
In this way, they can guarantee their labels are accurate and compliant, because they are printed based on templates and data housed in their own systems. They control who has access to what, and they get a complete history of every label that’s been printed. They can also manage labeling centrally and reduce security risks without placing an additional burden on IT resources.
Digital, cloud-based labelling can ease the burden on IT departments and expedite the label creation process. It gives MDMs an easy-to-use tool to visually lay out the label; a digital, visual workflow for quality control; the ability to automate mass label changes and approvals; and label printing that’s integrated with the business systems that house UDI data.
Seeing it as an opportunity
Ultimately, manufacturers need to take advantage of the opportunity that MDR compliance presents. By adopting the right technology and implementing a digitised cloud-based labelling approach, they take cost out of their quality control and integration processes and minimise IT resources.
They can also drive agility in this way. If manufacturers can ensure they are compliant with EU MDR and if they have standardised on a modern digital system, ideally in the cloud, they will be well-placed to make any adjustments required to comply also with new UDI requirements of national and regional regulations yet to be put in place. The more agile their system is, the better prepared they will be to handle the regulatory future.