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While 510 (k) is the preferred regulatory strategy of many North American medical device companies, launching in Europe first with a CE mark can be beneficial. This blog concludes my highlights of 510 (k) and CE Marking similarities and differences. Last week I covered Terminology, Device Risk Classification, and Process.What is the difference between premarket approval and 510 (k)?
The reason 510(k) is the preferred regulatory pathway to reach the US market is clear: Large single market with a transparent regulatory body and minimal costs compared to Premarket approval (PMA). Clients sometimes assume that once the 510(k) is in place it will be trivial to obtain a CE mark and start exporting to Europe.Is the FDA or CE marking better for medical devices?
As one medical device company founder says of the CE marking, “there is no guarantee that the device will be widely accepted by physicians or reimbursable by the government in each European country” (Chi 2012). It is possible too that the FDA’s strictness is seen as safer for consumers.Do I need a risk analysis for my 510k?
However, risk analysis is only a small portion of a risk management file. Only 10-15% of 510k submissions require clinical studies, but 100% of medical devices with CE Marking require a clinical evaluation report (CER) as an essential requirement in the technical file.