CE versus FDA registration pathway for medical devices

Navigating the regulatory environment around medical devices has never been easy, especially in the case of manufacturers and resellers working across global supply chains. In the fast-evolving world of medical device regulation, there are two well-established registration pathways: CE and FDA, both of which are essential for devices sold and used in the EU and the US respectively.

Deciphering CE markings and FDA approvals

While the CE and FDA standards have some similarities, there are a few important differences, particularly with regards to scope. They both use a classification system and follow predictable and highly standardized registration processes. All medical devices sold in the EU must have the CE marking, while those sold in the US must be registered with the FDA.

The CE marking is denotes that the device conforms to the health, safety, and environmental standards of the European Union. CE itself is an abbreviation of conformité européenne, which is French for European conformity. The CE marking applies to a huge range of product groups, including medical devices, electrical devices, machinery, radio equipment, and toys.

The Food and Drug Administration (FDA), by contrast, is a federal agency of the Department of Health and Human Services in the US. As the name suggests, FDA approval chiefly applies to the safety standards concerning food and drugs. However, it also includes medical devices and devices that emit electromagnetic radiation.

What are the pathways for medical device approvals?

The choice between the two registration pathways is not necessarily an either/or one. It largely depends on where the medical devices are to be distributed or used. That said, both pathways take a different approach. The FDA assesses medical devices in terms of effectiveness and risk of harm, while the CE marking simply affirms that the product conforms to health, safety, and environmental standards in the EU.

As such, FDA approval has a stronger quality control mechanism than the CE. However, this also means that the approval process can be lengthier and more complex. By contrast, a CE marking does not necessarily mean that the device is effective; only that it conforms to safety standards. This generally makes it easier to obtain a CE marking, but it also means there is a higher risk of the market being flooded with low-quality products that, while safe, might be ineffective.

Due in part to many exemptions and multiple registration paths, FDA approval has long been viewed as more time-consuming and cumbersome than obtaining a CE marking. While that is still the case to an extent, medical device manufacturers are increasingly prioritizing FDA approval over CE marking. This is partly due to Brexit, with the UK planning to replace the CE marking with its own regulations in June 2023. For global medical device manufacturers and distributers, this significantly reduces the value of the CE marking. Unfortunately, however, this also means residents of the EU may suffer delayed access to new medical technology.

The new medical devices regulation (MDR) will further complicate the process for obtaining a CE marking, but it will also bring the standards closer in line with those of the FDA. The UK is also drafting its Medicines and Medical Devices Bill, which is intended to align closely with the MDR, thereby indirectly making the CE marking more impactful. In other words, registering for conformity with the FDA, MDR, and the UK’s new bill should become a lot more similar to the extent they could be done in parallel.

Ideally, medical device manufacturers should pursue both in order to distribute their products in both the EU and the US, as well as other countries that have similar standards. Fortunately, modern data-driven solutions can greatly simplify these processes by providing regulatory, business, and clinical intelligence at scale to help drive informed decision-making. In today’s data-driven world, there is simply no better way to ensure that as many patients as possible have access to novel medical technology.

NyquistData’s AI-powered tools provide trusted intelligence on medical devices to help uphold regulatory demands and unlock hidden insights from unstructured life sciences data. Contact us today to find out more.

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