There are established quality control systems for the use of medical devices all over the world. There are differences between these documents. The most important ones are CE Mark (MDD) used in Europe and FDA Approval used in the United States.
CE Mark (European Medical Device Use Certificate):
It is defined as the use of a medical device or drug in European territory and the quality control system after use. So it's not "just" a permission, it's a quality control system. After the product is put on the market, both clinical research and test results are requested alternately, the certificate must be renewed, if it cannot be renewed, the product is withdrawn from the market.
Its main function is to evaluate the safety and effectiveness of new devices.
It is a license defined by its name . In other words, the medical device is licensed for use in the United States.
• The main function is to evaluate the safety and effectiveness of new devices.
• Requires comparative clinical research or trial
• Approves narrow parameter range
• Valid in the United States only
• Compared to CE Marking, it is more expensive to obtain because the documents required from inspectors are much less efficient, the inspection cycle is about three times longer, and there are almost always more rounds of questions.
• Indicates that strict criteria are met for clinical application of a drug or device to be safe and effective.
In conclusion :
Companies that do not want to enter the American market do not want to get FDA approval. Because sometimes entering a market can bring investment, cost, labor and risks. However, when a good and quality product cannot enter the American market, the American people are left in a disadvantaged position. There are many examples of this. For this reason, CE Mark is more accepted and is a valid system all over the world. MDD has now been replaced by MDR. Although it forces many companies, it is stated that CE MDR may become superior to FDA and may fall into the "Gold Standard" position in the near future.
Many Medical Devices (For example Heart Valve) have been used for years in Europe and all over the world, even though they are not FDA Approved. Another Example is Long-acting Insulin which is given to children everywhere, although it is not FDA-approved for ages 0-5 . Although many products of some famous global medical device companies cannot get FDA approval, their sales and use continue all over the world.
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