FDA and CE approval

When it comes to maintaining the conformity with both US FDA’s regulations and the European Union’s (EU) Medical Device Directive (MDD), which transition to the new Medical Device Regulation (MDR), Medical Device companies undoubtedly encounter some difficulties.

In May, 2017 the European Commission put forward a new Medical Device Regulation with reference Regulation (EU) 2017/745 (hereafter: MDR 2017/745). This new Regulation will become fully effective from 2020 by replacing the current Medical Device Directive (MDD) 93/42/EEC that regulates medical devices. Read more about this in a previous article we wrote.

The struggle increases for the companies who have obtained an FDA premarket approval because they find the MDD requirements complex. If a company wishes to make their products/services accessible to both American and the European markets, there are some general but essential terms and procedures, which one should be knowledgeable about. Have a look below to learn more.

Conformity Assessment

Conformity assessment is the process and procedure by which manufacturers show that their medical device meets CE Marking requirements. This varies depending on the class of product. The EU has four classes:
1. Class I
2. Class IIa
3. Class IIb
4. Class III

While FDA has three classes:
1. Class I
2. Class II
3. Class III

It has been evident that in the US submission for the products in the same class, the requirements for premarket notification (510(k)) for the products’ acceptance are different from premarket approval (PMA).

EU product approval submissions are based solely on class and each submission must meet exactly the same requirements. Thus, products with superficial 510(k)s that lack technical documentation will be at a disadvantage, compared to the products that have recent comprehensive 510(k)s or PMA applications.

We will learn more about some other differences and similarities below.

Similarities and differences between the EU Technical file and US 510(k)

There is an obligation for the companies in the EU and the US markets to process and compile sufficient technical documents of their products to pass the safety test.

Technical File is an EU term that is used to describe the documentation created for Class I, Class IIa and Class IIb products. Class III products have a different technical file name that is called: Design Dossier.

The equivalent of the technical file in the United States is:
1. 510(k) > for products that are similar to others already on the market
2. PMA application > which is required for class III and high-risk Class II devices.

In Annex I, the MDD has set forth a checklist of the factors that could affect the safety of a medical device. It forms the basis of the essential requirements that a product should comply with.

The Technical File also includes the European norm (EN) harmonized standards and other standards that are important to pass the EN conformity standards.

There are some hundreds of EN harmonized standards applicable to the medical devices. These standards can be divided into two categories of factors affecting the devices. One includes risk assessment, packaging, labeling, and instructions. The other one encompasses more medically inclined factors like gamma or ethylene oxide sterilization. If there are no applicable European standards, other standards such as national or international standards, go into effect.

Needless to say that to claim compliance with the standards, it should be backed by the results of various assessments like risk analysis, results of testing, safety reports, clinical trial data etc.

The EU documentation is more detailed and structured than the FDA. However, the good news is that the FDA has increased the range of information it requires to include technical and safety standards for risk analysis. So the companies, who will be applying for the FDA certification, or have recently completed the process, will obviously meet most EU requirements

This brings us to the last part, which is, sterile and non-sterile devices.

Quality assurance for Sterile and non-sterile Devices

The EU doesn’t allow the companies to overdose the devices with chemicals during their manufacturing and packaging process. The FDA permits higher levels of sterilant making it difficult for the US manufacturers to pass the EU quality system requirements for sterile devices. Class I non-sterile devices should be able to meet 85% of EU requirements.

Translations for labelling

Another important factor that makes the process a little difficult is the translation in multiple languages. If a company wants to sell a device in all 15 EU countries, it may need labelling translations in 12 languages.



Many face the challenge on how to bridge the gaps between these regimes in order to acquire product access in both markets. Companies who have obtained a FDA premarket approval find the MDD requirements complex.

Furthermore, in the US submission for products in the same class have historically had different requirements for premarket notification (510(k)) as opposed to premarket approval (PMA), whereas EU product approval submissions are based solely on class, and each submission must meet exactly the same requirements.

In the EU the term Technical File is used to describe the file is compiled for Class I, Class IIa and Class IIb products. Class III products have a different technical file called: Design Dossier. In the technical file, the EU requires documentation organized in a more detailed, structured, and specific way than required by FDA. In Annex I, the MDD sets forth essential requirements that establish minimum safety considerations.

US Manufacturers of Medical devices face greater challenges in the quality system requirements for sterile devices then for non-sterile devices.

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