Going Beyond the Regulations to Evaluate Relevant Medical Device Risk.

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Author: Sherry Parker
Date: June 2020
From: Medical Product Outsourcing(Vol. 18, Issue 5)
Publisher: Rodman Publishing
Document Type: Article
Length: 1,553 words
Lexile Measure: 1340L

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Many companies are working overtime to ensure lifesaving medical devices get and stay on the market. While efficiency is key, important steps can slip through the cracks when speed is the priority. If companies feel pressure to rush and focus solely on satisfying standards, there's a chance their device's success could be limited to the short-term in our fast-paced industry and regulatory environment. Going the extra mile can help prevent minor changes from snowballing into bigger issues.

Companies need to review their testing plan so it supports a successful submission, saves time on the back end, and ensures the long-term success of their product. To avoid potential setbacks, they should use the following steps to identify and evaluate the relevant risks for each device, instead of simply meeting what regulators require.

Do: Start with a clean portfolio. Whether these preparations already started for the Medical Device Regulation (MDR) or capacity constraints have forced prioritization, now is the ideal time to prioritize product portfolios and pull devices from the market that aren't delivering necessary value. Many companies have already pulled devices from the European market where it doesn't make sense to update the files and registration under the MDR. It may be time to extend this process to other markets, or with non-critical devices. While these decisions may lead to a predicted reduction in the total number of available devices, they also allow companies to focus on more pressing needs.

Don't: Depend on device class. Another lesson learned from the transition to the MDR is how quickly device classifications can change--the implications of which can be frustrating and time-consuming. Staying ahead of classification changes takes diligence and proactive research. The necessary chemical characterization and toxicological risk assessment requirements vary depending on the risk level and regulatory body. These discrepancies can lead to gaps in technical files when a device changes classifications and testing results no longer meet appropriate standards.

When approaching testing to satisfy regulatory needs, it's important to look not only at the current device classification but consider its future potential throughout the product lifecycle. Those going beyond what regulators currently require are typically better prepared to meet future needs.

Taking steps to go further when it makes sense could also help meet product standards across multiple regulatory bodies. For example, while the FDA and MDR closely align...

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Gale Document Number: GALE|A628407276