A Deep Dive into Medical Device Safety as Reported by the Johner Institute
A comprehensive analysis of the safety and reliability of medical devices approved by the United States (US) Food and Drug Administration (FDA) as compared to those complying with European Union (EU) regulations was conducted and presented in an expert report commissioned by from the renowned Johner Institute. The key findings and results from this report are reassuring for the life science community and are outlined below:
- FDA-approved medical devices are confirmed to be as safe as adhering to EU regulations.
- Both regulatory frameworks maintain rigorous standards for device development, manufacturing, and monitoring.
- Market access and post-market surveillance requirements are risk-based in both systems, emphasizing safety and performance evidence.
- Notably, medical devices in the US undergo centralized evaluation, approval, and monitoring by the FDA. Conversely, in the EU, assessment and oversight are decentralized, involving national authorities and state-authorized private entities known as Notified Bodies, which can result in varied interpretations of regulations and differing perceptions of product compliance.
- Another distinctive feature is the acceptance of comparative products. The US’s 510(k) clearance process facilitates simplified approval of moderate-risk medical devices through the principle of equivalence, often without the need for independent clinical data. Many US products gain clearance via this route. However, with the introduction of the Medical Device Reporting (MDR), the equivalence process in Europe has significantly narrowed, limiting its applicability to CE-marked products, thus requiring EU products to furnish more proprietary data demonstrating safety and performance before market release.
In summary, no significant safety concerns have been identified between the devices approved for the US and EU markets. Medical products from both regulatory domains are developed, manufactured, and monitored under comparable high standards.
In November 2022, the Swiss Parliament voted in favor of accepting medical devices with US FDA marketing authorization in Switzerland, despite the opposition of the Swiss Federal Council, who cited, among other reasons, patient safety concerns due to the difference in review process between US FDA and European Notified Bodies. This new report shows that the Swiss Federal Council worries were unsubstantiated. Switzerland is now ready to expand its spectrum of available medical devices of FDA-approved devices and products to include those approved by non-European regulatory systems. This expansion promises more options for sourcing, potentially translating into improved patient care and the fostering of innovation.
While this diversification of devices helps mitigate supply chain risks, it also can bring about heightened competition. Manufacturers will be compelled to continually elevate their offerings, ensuring alignment with the stringent safety criteria set forth by different regulatory bodies.
At anteris by Kymanox, we are excited about the immense growth and innovation potential that this expansion will bring to the industry. Our goal is to have the highest standards of excellence, safety, and pioneering healthcare solutions for Switzerland, and the rest of the world…because patients deserve better.
Curious about how Kymanox and our family of brands, including anteris by Kymanox, can facilitate your journey in this evolving landscape? Reach out to us today here and learn more about our EU division at www.anteris-medical.com.