Comparing the different certification requirements for medical markers in the EU and the US

This article compares the EU CE mark with the FDA's medical device approval process, including the certification procedures, regulatory differences, and key points of which businesses should be aware.The book is intended for medical devices manufacturers, exporters, and regulatory affairs personnel to help them quickly grasp the rules for entry into these two markets and avoid regulatory risks caused by differences in the two markets.

Why do the CE and FDA requirements differ?

Many medical device manufacturers who are just beginning to enter international markets wonder why, if their products meet European Union standards, they have to go through the hassle of meeting FDA standards. The reason is that the design logic behind the CE and FDA systems are different.CE certification by the European Union is based on "self-declaration," so after a company passes a conformity assessment, it can affix the CE label. The FDA, on the other hand, is like a "strict examiner" that requires substantial reviews before allowing a product to be sold.

This is a core feature of the CE certification process.

Flexible management by classification.

The EU divides medical devices into four risk classes, I, IIa, IIb, and III.For example, ordinary surgical gloves are class I devices, and firms can get them certified themselves. But a heart stent is a class III device, and a firm must find a designated body to do the certification.This "tailor-made" design saves costs and hits the point.

Technical documentation is the core.

Technical documentation is a kind of "health report" for a product, and should include design principles, test data, and clinical evidence.One company was caught in a customs check because it lacked sterilization data in its documents--so don't think that "close enough" is good enough.

The FDA's tough requirements.

The difference between 510(k) and PMA.

The FDA has two routes for approval. Products on the 510 (k) track must prove that they are "substantially equivalent" to products already on the market, and are therefore suitable for improved devices. But completely new high-risk products must go through the PMA process, which can require three years or more of clinical data.

The factory inspection cannot be avoided.

Even after a product is approved, the FDA can fly in and inspect the factory at any time.Last year, a Shenzhen manufacturer was banned from exporting to the US after it was found to have falsified records of temperature and humidity in its production facility.Their lesson is that quality control is not just something to be done in preparation for an inspection, but something that has to be taken seriously every day.

The three key differences that enterprises should be most concerned about.

Clinical data.

The EU accepts clinical data from overseas, but the FDA is more willing to accept data from trials conducted in the United States.The manufacturer of a respirator, for example, was caught unawares--when it applied for FDA approval using European data, it was asked to conduct additional studies on North Americans, which wasted half a year.

Labels and instructions.

CE labels must include a certification number (such as CE 0123), while FDA labels must include a warning that the drug is "prescription only.One company once sent its products to the US with the EU label translated into English, only to have its shipment held up by customs for lack of the "Rx only" designation.

Post-listing supervision.

The EMA mainly relies on companies to report adverse events. The FDA, however, actively gathers data from hospitals and patients.Statistics show that the FDA initiates more than 300 recalls of medical devices each year, a much stricter standard than that in the European Union.

Which certification route is the most cost-effective?

If your budget is limited, I suggest you first obtain CE approval to open up the European market, since the time period is short (typically six to 12 months).They will wait until they have sufficient funds to try again with the FDA, since the US market has a high profit margin.But it's important to note that for emerging products like AI diagnostic software, the FDA might actually be faster than CE. Their "Breakthrough Devices Program" provides a fast track.

Finally, a reminder: Some third-party organizations claim that they can "handle the CE and FDA approvals for you." Don't believe them! These two systems are completely different, and you have to go through the entire process for each.