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Whitepapers

Are There Common Denominators Between the European and the US Regulations?

As previously discussed1, clinical data are a requirement for market authorisation of a medical device, regardless of the jurisdiction. In terms of terminology the US regulations refer to clinical trials for both medicines and medical devices as "clinical studies". The European terminology differentiates between "clinical studies" for medicinal products and "clinical investigations" for medical devices, which is also the terminology used in the international norm ISO 14155 (2011). In this paper we will use the two terms interchangeably. Note that in the context of medical device regulations, the term "Europe" encompasses all 27 European Union countries plus Switzerland, Liechtenstein, Iceland, Norway and Turkey.