How medical device manufacturers can solve labelling validation and compliance challenges
Susan Gosnell, product manager, NiceLabel, looks at the compliance and validation challenges medical device manufacturers are currently facing in meeting regulations such MDR and FDA, and considers how they can best tackle this through their labelling management systems.
Medical device manufacturers work in a highly regulated environment. They need to ensure they align their processes with stringent standards like the EU Medical Device Regulation (MDR) and US Food and Drug Administration (FDA) regulations. That presents challenges when it comes to achieving compliant labelling.
Medical device manufacturers that were previously shipping products to the US and had achieved compliance with the FDA regulations may be 90% of the way to complying with MDR also. However, they must not rest on their laurels because there are some nuanced differences between the two sets of regulations. Some of the biggest differences relate to label design.
Creating an MDR-compliant label brings with it certain requirements which differ from what is asked for under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers have to ensure that the label used specifically states that the device is a medical one using a MD symbol in a box. That’s one of a raft of stipulations. Meeting all these typically involves organisations carrying out a lot of work redesigning labels.
This will be a difficult task, especially if the medical device manufacturer is hard-coding label designs using programs like SAPscript, and they have hundreds or even thousands of label templates to work through. The possibility of labelling errors presents a huge challenge also. In a regulated industry, like medical devices, an error could result in non-compliance. Penalties may include having to quarantine products and shipping delays. In other words, errors can really hamper and hold back the whole process. So, what is the solution? How can medical device manufacturers overcome these challenges?
Finding a Way Forward
Switching to dynamic templates from hard-coded ones will ease the burden on IT when it comes to label design changes. Having an intuitive user-friendly tool to do those label changes can be helpful.
Furthermore, by digitising the whole quality assurance/quality control process, manufacturers can address any issues they might have with mislabelling and errors. If they digitise the whole process, manufacturers can put workflows in place for label changes and approvals. This means they are not so reliant on manual processes or printed proofs, nor so vulnerable to associated human error.
By extension, manufacturers can automate label changes en masse as well as the approvals that streamline that whole label updating process. Instead of creating hundreds of thousands of label designs for each stock keeping unit (SKU), that would then entail each be approved, medical device manufacturers can now do that en masse. They are in effect creating an approved label template for each SKU and then that’s locked down with the device identifier (DI) data which is required for the UDI portion of both EU and US regulations. With that in place, labels can be readied for production, at which point production identifier (PI) data, derived from manufacturing execution (MES); product lifecycle management (PLM) and enterprise resource planning (ERP) systems, can be added and merged.
Seamless integration between labelling systems and PLM, ERP or MES systems that are the source of this DI and PI data is key to a smooth and efficient labelling process. The emergence of validation-ready cloud labelling solutions is driving further efficiencies. Carrying out labelling in the cloud drives scalability and productivity for medical device manufacturers as well as supporting enhanced efficiencies.
The latest cloud labelling solutions can support cloud to cloud integration, allowing cloud labelling solutions to integrate with other cloud solutions. They can also have validation documentation to ease the validation workload on IT and a relaxed update schedule, say once/year, further easing the burden on IT.
Putting a process in place
A modern labelling system will include compliant label templates which will ease label design, but compliance goes further than the design itself. Having a labelling process that supports a quality process will streamline compliance.
Digitised workflows can be put in place to streamline the whole compliance effort and support everything from role-based access to document versioning, configurable approval workflows, electronic records, and electronic signatures; and a 12-year print history. All these capabilities together supported by a good solid process will just help to simplify and streamline the whole compliance effort. And when it comes to validating the labelling system and process, documentation required for installation qualification (IQ); operational qualification (OQ) and performance qualification (PQ) processes will help streamline the effort and reduce the IT burden.
As we have seen, moving to the cloud can also bring significant benefits to medical device manufacturers in terms of managing compliant labels; delivering all the advantages of a full-blown label management system without the investment in the infrastructure and the need for extensive IT support, which would be required if they were hosting the system on site.
Of course, it is one thing to deliver a compliant labelling process at any one time; but it is quite another to be able to continuously adapt labelling in order to remain compliant. Changing regulations do, however, offer medical device manufacturers a great opportunity to uncover hidden costs and problems they might have in their existing process.
They need to look at where there are hidden costs that could be eliminated or inefficiencies that could be ironed out. They need to identify all the stakeholders in the compliance initiatives. They need to understand the role IT will play when regulatory and quality teams get involved. Only once all these elements and the process are fixed, should modern labelling systems be added on top.
That’s where the latest cloud-based labelling systems come in. This technology is future proof. Medical device manufacturers can be confident that vendors will be continuously updating it, enabling companies to address the fast-changing upcoming new regulations and be able to cope with whatever comes their way. And especially in these times, when people can’t be together in person, it’s a perfect way to keep labelling operations moving forward.