CE Mark or FDA Approval?

Which accreditation is right for my medical device?


The answer is a resounding “well, it depends…”

It depends on many factors including the specific circumstance, position, timelines and ambitions you have for your device and your company. This article summarises some of the key differences, positives and negatives in order to augment your pathway selection processes.

Some Key Differences

  1. FDA approval always requires bespoke clinical trial data. In comparison, CE mark can be obtained following utilisation and application of successful clinical evaluations of equivalent pre-existing devices and a subsequent post-market study.
  2. CE mark requires proof of the safety of the device usage. FDA approval, on the other hand, requires proof of the safety and efficacy of the device. It must be noted here that CE marked devices will necessarily then be required to provide proof of efficacy on a country-by-country basis to achieve reimbursement, although the acquisition of these proofs is expedited by successful CE marking.
  3. Federal oversight of the Food and Drug Administration Agency and subsequent nationwide reimbursement processes (i.e. Medicare) mean that FDA efficacy proofs are much less open to interpretation and variation than those obtained in the EU (currently comprising 28 nations and sets of regulations). As mentioned, devices in the EU must satisfy multiple country-specific efficacy requirements whilst FDA efficacy supersedes state law and (theoretically) provides successful applicants with instant access to the world’s largest market for Medical Devices.
  4. One of the key predicates of venture capital funding is the ability of a business to demonstrate a workable strategy to obtain a tandem accreditation, where both FDA and CE marking are pursued concurrently. Tandem accreditation may require the most substantial resources, but it does the most to minimise risk and delay.
  5. On average, CE marking processes tend to be faster and cheaper than FDA.

The Processes

The Class III CE Marking process (Class I and II are even shorter):

  1. Identification and implementation of a valid conformity assessment procedure:
    • Notified body studies technical design versus the legislative instruments (directives) which apply to it (Module B)
    • Full QA and design dossier examination by notified body (Module H)
  1. Technical file submission
  2. Device manufacturer declares conformity and appoints an authorised representative
  3. Proper packaging and labelling of the newly accredited device
  4. Post-market surveillance

The FDA Process:

  1. If the manufacturer is claiming substantial equivalence to a pre-existing device the process can begin with a 510k pre-market notification. This requires the manufacturer to prove deep technological, design and performance-related similarity to the equivalent device. Without sufficient proof of equivalence, the device falls into Class III and requires pre-market approval (PMA).
  2. Appropriate classification of the device.
  3. If a device is classified as lower than Class III it falls within the ambit of 510k submission requiring proof of substantial equivalence. Devices categorised as Class III will require pre-market approval.
  4. If a manufacturer is unable to prove substantial equivalence to an existing device, the FDA can continually request data until satisfied, or where it feels that equivalence cannot be proven it can categorise the device as Class III by default and it must then pass through the PMA instead.
  5. Clinical trials are an essential element of the clearance process. As a general rule, these trials should take place within the US. A company can obtain investigational device exemption (IDE) for trials conducted outside the US in support of a PMA on the condition that it complies with IDE regulation. Additonally, IDE may only support and not replace in-US clinical trials.


It’s difficult to draw too many conclusions on this topic without venturing into the realms of over-simplification and generalisation. Still, the following truths are self-evident:

  • If you want your device to become commercially available, you will need to obtain a regulatory approval. Depending on your company’s location and your market penetration strategy, you will start with either FDA or CE Mark, but ultimately, if your technology has the potential to disrupt clinical practice on a global scale, you will need both.
  • Making informed decisions about getting marketing authorisation, especially within the context of ever-tightening regulatory parameters, requires expert knowledge, experience and, more often than not, a strong industry network.

Guided Solutions has been identifying and delivering transformative talent to growth-led, technology-driven Medical Device SMEs for nearly 20 years. If you need to get proven regulatory affairs expertise on board to make a successful next step in your product’s lifecycle, don’t hesitate to get in touch for an exploratory discussion.

Our seasoned team of international consultants and continually expanding global network of 120,000+ medtech professionals will deliver the right fit for your team.