Limited resources need not determine whether small medical device manufacturers can meet labelling compliance and validation requirements says Susan Gosnell, product manager at Loftware.
Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes. Validating systems and processes, including labelling, to ensure they are compliant with stringent regulatory standards is tough and occasionally expensive.
If companies bungle the software validation process or put incorrect and noncompliant data on the labels, they are likely to incur penalties including compliance failure fines. Some companies attempting to comply with regulations in other geographic regions that focus on device traceability, each with a unique device identifier- (UDI) like component, can find the whole process overwhelming, particularly if they have only a small and busy IT team.
Putting a plan in place
MDR-compliant labelling has certain requirements which differ from those demanded under the FDA’s UDI system rules; for example, under MDR, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box.
Small medical device manufacturers who rely on time-consuming and error‑prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling, which can lead to noncompliance. They may have limited staff numbers and lack structured processes concerning roles and responsibilities pertaining to label design, changes and approval. As project leads work toward a compliant labelling process, it is important, therefore, to establish defined roles and access for each stage of the process.
When dealing with a compliance initiative, up-to-date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with MDR or FDA regulations. Frequently, label templates are hard coded, meaning IT staff must be involved in making changes. These personnel are often tasked with multiple mission‑critical projects in the organisation, which can delay labelling projects. For many small manufacturers with limited resources, finding a solution can be a challenge.
A roadmap forward
Validation-ready cloud labelling solutions have emerged to ease regulatory compliance and time‑consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role‑based access, approval workflows and electronic signatures. Outside of compliance, cloud‑based labelling drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.
The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.
Similar to many labelling systems, validation systems hosted in the cloud have vendor‑supplied documentation that streamlines the process and eases the burden of installation qualification. A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once rather than multiple times a year, giving them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.
The manufacturer will need to work closely alongside the vendor and review the documentation. If needed, the vendor can provide the full validation acceleration pack, as well as professional services to assist with simplifying the validation process. Tailored consultancy and advice concerning validation is usually available from the vendor.
Given the considerable hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system to ease compliance and validation. With this future‑proof technology, medical device manufacturers can be confident that they are running the most up‑to‑date software, enabling them to address fast‑changing new regulations.