Many manufacturers run into issues as they adjust their devices and testing plans to meet updated regulatory requirements. Using a risk-based approach to predict and mitigate risks can help prevent costly setbacks.
Sherry Parker, WuXi AppTec
(Image courtesy of WuXi AppTec)
Between the EU Medical Device Regulation (MDR) delay and other regulatory bodies shifting priorities due to COVID-19, manufacturers are scrambling to stay up to date on regulatory changes and keep their products on track for compliance. Simply working toward the current requirements checklist could potentially lead to regulatory complications, which is why experts recommend taking these requirements further.
A thoughtful, risk-based approach can help ensure that nothing in the testing plan slips through the cracks and threatens submission success. Following certain steps below can help manufacturers gain confidence in their testing plan.
Documentation longevity
Device documentation and testing information must be thorough and transparent enough for someone removed from the testing altogether to understand what was done and how it was done. Assuming that the next person to reference the documentation of completed testing will have adequate background knowledge and experience to understand it could cause significant issues.
Teams change, and it is crucial to set future colleagues up for success by providing a road map of past decisions regarding the device, the materials used, the testing history and more. Testing partners can help ensure your document includes the appropriate details, regardless of personnel changes.
Device classification
It is vital to be proactive when it comes to device classification. The new MDR guidelines have proven this to be an element of medical device testing that can change quickly and send a manufacturer back to the drawing board.
Manufacturers must have a thorough understanding of their device’s classification. The potential classification offers a guide to what non-clinical testing work might be needed, along with possible steps for submission. For example, Class II devices generally require more testing than Class I devices, which can set manufacturers on a different trajectory and ultimately lead to delays if done insufficiently. It is also essential to test the final finished device, which may not be addressed by only testing materials and/or components.
Additionally, Class I (reusable) devices, such as surgical instruments, are under higher levels of scrutiny than ever before with MDR guidelines. It is essential to understand what it takes to prepare devices for submission to meet these regulations.
Staying ahead of classification regulations requires thorough research and a team of qualified experts. Consider what the regulatory landscape may look like for the entirety of the device’s lifecycle and work with the mindset of exceeding regulatory expectations now for more leeway later.
Post-market considerations
Strategically prepare for post-market successes and challenges when planning beyond regulatory submission. Surveillance throughout product life cycle is not an area to cut corners. For example, if post-market monitoring reveals an unforeseen color change/chemical reaction, be sure to diligently investigate this. Working with a testing partner can help determine the next steps.
The work is not over when a regulatory body gives the stamp of approval. Listen to the end-users — patients and physicians — for feedback on how the device is operating outside the testing lab. Continuous monitoring will help improve the device and provide insight for future projects.
Packaging & labeling
While not high on the priority list, packaging and labeling must be considered early in the process to meet regulatory requirements and avoid submission delays. Ensure that the intended clinical uses and instructions are not only documented well in study data but also prioritized for packaging. Bringing in the marketing team early can help with this process.
Also, don’t forget to test the device from its final packaging to detect any leachables transferred to the final finished device. It might seem unnecessary now, but planning packaging and labeling during device testing can expedite the process and keep the device on track to meet the submission timeline.
Sherry Parker is senior director regulatory toxicology at WuXi AppTec Medical Device Testing (St. Paul, MN). Parker also serves as a member of ISO TC 194, WG 11 and is U.S. co-chair of the ISO TC 194 Mirror Committee.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.
