FDA and CE approval
Many Medical Device companies struggle with how to comply with both US FDA’s regulations and the European Union’s (EU) Medical Device Directive (MDD). They 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. Despite the differences, CE and FDA have one common goal. Ensuring that medical device manufactures produce and market (continuously) safe products that comply to the applicable regulations. And to ensure good manufacturing and design control.
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
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. Thus, products with superficial 510(k)s that lack technical documentation will be at a disadvantage compared with products that have recent, comprehensive 510(k)s or PMA applications.
Similarities and differences between the EU Technical file and US 510(k)
In the EU and US companies are obliged to require sufficient technical documentation of the product intended for regulators to review and determine the safety level. 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.
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 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. These essential requirements are a checklist of factors that could affect the safety of a medical device, such as design, construction, packaging, and labeling.
For each applicable essential requirement, the technical file must also include the European norm (EN) harmonized standards and other standards used to demonstrate conformity to the EN standards. Harmonized safety standards have been written specifically to provide a path for demonstrating conformity to the relevant directives. There are hundreds of EN harmonized standards applicable to medical devices; some of these apply to broadly defined factors affecting a wide range of devices (e.g., risk assessment, packaging, labeling, and instructions), while others apply to more-specific areas (e.g., gamma or ethylene oxide sterilization). If there are no applicable European standards, other standards—such as national or international standards—may be invoked.
The technical file must also include evidence for claiming compliance with the standards or applicable clauses in the standards—for example, results of a risk analysis, results of testing, safety reports, clinical trial data, equivalence to other products.
Good news is that FDA has increased the range of information it requires to include technical and safety standards, risk analysis. Therefore companies that have recently developed comprehensive 510(k)s and PMA applications should meet most EU requirements. For older 510(k)s the situation however, is different. When 510(k)s were initially created, they typically lacked the kind of technical documentation that the EU now requires.
US Manufacturers of Medical devices face greater challenges in the quality system requirements for sterile devices then for non-sterile devices. The EU requires companies to control the manufacturing and packaging environment to achieve a sterilization assurance without overdosing with chemicals. FDA has taken a more relaxed view of sterilization, allowing higher levels of sterilant.
Sterile and non-sterile Devices
Simple FDA Class I nonsterile devices should be able to meet up to 85% of EU requirements. The differences between the EU and U.S. requirements are the multiple translations for labeling and use in the EU. Eventhough this is a minor change, translation could be a significant issue. If a company wants to sell a device in all 15 EU countries, it may need labeling translations in 12 languages.
Certification Experts can assist you in each step to fullfill al needs with regards to EU and US market access approval. We are highly experienced in helping companies obtain a variety of different certifications.