Prime Scientific - The Importance of FDA and CE Certification in Invitro Diagnostics

Introduction

With the aftermath of the COVID-19 pandemic, and the entry of new players in the medical devices market; we have learnt the importance of certification and conformity. These certifications govern the standards under which certain items used in the medical field are produced; thereby maintaining a conforming protocool over all such items. This also helps ensure that diagnosis results produced from similar devices under the same conformity certification are comparable and that their results are reproducible under similar laboratory conditions.

There are many governing bodies that provide certifications for medical devices. Examples of such bodies are the European Union, The United States FDA, and the International Standards Organization (ISO). Each of these major bodies provides a clear set of requirements for designing and producing medical items; that classify these products under certain categories (or classes), and specify certain parameters to conform to. Medical devices or items that conform to such parameters are then certified by these bodies after undergoing a rigorous assessment. Once a medical item is certified, then it can be freely distributed in the teritorries governed by these bodies, or any territories adopting their standards.

Now  understand the importance of these certifications, but what is the difference between each type of certification? Like US-FDA or CE certifications?

CE Certification

This stamp of approval, symbolized by the CE logo as seen on the left, stands for "conformité européenne" (European conformity). The CE mark is affixed to products, for the sake of this article, medical devices, that have successfully satisfied the requirements of the MDR (Medical Device Regulation). A medical device can therefore only be placed on the European Union market without the CE mark.

In order to achieve the CE Mark Approval, the following steps need to be followed:

1. Select the applicable product standards and test methods for your product and select a Notified Body.
2. Establish an Authorized Representative in the European Union for your product.
3. Produce a Technical File for your product
4. Prepare a Declaration of Conformity.
5. Register your product in EU
6. Affix the CE Marking to your product.

FDA Approval

FDA approval for medical devices is a regulatory process through which the U.S. Food and Drug Administration (FDA) evaluates and authorizes the marketing of medical devices in the United States. The approval process aims to ensure the safety and effectiveness of medical devices before they reach the market. It involves a thorough review of the device’s design, performance, labeling, and manufacturing processes. There are different pathways for approval, including 510(k) clearance, Premarket Approval (PMA), and the De Novo classification process, depending on the device’s level of risk. Compliance with FDA regulations is essential for companies seeking to market and distribute medical devices in the U.S.

The 7 major pathways to market in the U.S. include:

1. Premarket Notification 510(k)
2. Premarket Approval (PMA)
3. De Novo
4. Humanitarian Device Exemption (HDE)
5. Custom Device Exemption (CDE)
6. Expanded Access Program (EAP)
7. Product Development Protocol (PDP)

Depending on the product, the most suitable path is chosen to gain the FDA approval. After the FDA approval is obtained, the medical device can be distributed in the US market and in any other market that adopts or accepts the US FDA approval.

CE or FDA Approval?

The CE Mark in the European Union and the FDA-approval process in the United States both perform the same functions, namely assessing the safety and efficacy of new devices. FDA approval, however, is significantly more expensive to obtain for a number of reasons:

1. The documentation required from investigators is much less efficient for FDA submissions than it is for the CE Mark.

2. The review cycle is about three times longer with the FDA.

3. There are almost always more rounds of questions with FDA-approval submissions than with those for CE Mark.

FDA approval always requires a full clinical trial or trials, whereas the CE Mark can be obtained through a clinical evaluation. The CE Mark is recognized almost globally—in addition to being valid in all countries of the European Union. By comparison, FDA approval is valid only in the United States. For this reason, it is more attractive to companies to apply for the CE Mark first.

Conclusions

It is safe to say that it is of utmost importance that any medical device or item that is distributed in the EU, US, or globally; is bound to conform to either the CE or FDA approvals; or any other regional or internationally recognized bodies, like the Japanese PMDA or the ISO. Although both the CE and FDA approvals have their pros and cons; both require a rigorous and time intensive process to obtain the certification. In any case, it is wiser to choose the approval that suits best the target market of distribution.

References

1. https://www.linkedin.com/pulse/why-ce-mark-matters-herv%C3%A9-mwamba?utm_source=share&utm_medium=member_mobile_web&utm_campaign=copy

2. http://www.ce-marking.org/how-obtain.html

https://operonstrategist.com/services/regulatory-approvals/fda-510k/?utm_source=usfda+paid+campaign&utm_medium=google+ads+&utm_campaign=google+ads&gad_source=1&gclid=CjwKCAiAuYuvBhApEiwAzq_YiRLG5dTtv_r_CYL5AOcnb3bhv4JRlR6YWwol0UBIkZATGVnEFd9LdxoC6mUQAvD_BwE

3. https://www.greenlight.guru/blog/fda-pathways-medical-device-to-market

4. https://crstodayeurope.com/articles/2015-feb/ce-mark-versus-fda-approval-which-system-has-it-right/