# Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access
## CE Marking
### United States of America
#### 4.2.1 Definition and Classification  
A medical device is defined by the FDA as \"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is recognized in the official National Formulary, or the USA Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes\" [12].  
The FDA classifies medical devices into three classes based on the level of risk they pose to patients and the necessity of regulatory controls to ensure their safety and effectiveness [54]. Class I devices are those that do not support or sustain life and do not present a potential unreasonable risk of illness or injury. These devices are considered to be of low risk. They are subject to the least regulatory control and must comply with general controls, which include provisions such as proper branding, labelling and adherence to Good Manufacturing Practices (GMP) [54; 55]. Class II devices are considered to be of  
\begin{table}
\begin{tabular}{c c c c c} \hline \hline
**Class** & **Sub-Class** & **Definition** & **Pre-Market** & **Post-Market** \\ \hline \multirow{4}{*}{I} & \multirow{2}{*}{I} & \multirow{2}{*}{Low risk} & \multirow{2}{*}{Technical documentation} & \multirow{2}{*}{} \\ \cline{2-3} \cline{5-5}  & & Isp & Sterile device & & \\ \cline{2-3} \cline{5-5}  & & Imf & Measuring device & & \\ \cline{2-3} \cline{5-5}  & & \multirow{2}{*}{Irs} & Reusable surgical instruments & & \\ \cline{2-3} \cline{5-5}  & & & & \\ \hline \multirow{4}{*}{II} & \multirow{4}{*}{IIa} & \multirow{4}{*}{Low–medium risk} & \multirow{2}{*}{} & \multirow{2}{*}{} & \\ \cline{2-3} \cline{5-5}  & & & & \\ \cline{2-3} \cline{5-5}  & & & & & \\ \cline{2-3} \cline{5-5}  & & & & & \\ \cline{2-3} \cline{5-5}  & & & & & \\ \cline{2-3} \cline{5-5}  & & & & & \\ \cline{2-3} \cline{5-5}  & & & & & \\ \hline \hline \end{tabular}
\end{table}
Table 1: Medical devices’ classification and regulatory requirements in EU.  
moderate risk. General controls alone are insufficient in assuring safety and effectiveness, so they need to be subject to additional regulatory controls called special controls. These controls may include performance standards, post-market surveillance, patient registries and guidance documents. Lastly, Class III devices are those that support or sustain human life, are of substantial importance in preventing the impairment of human health or which present a potential unreasonable risk of illness or injury. These devices are subject to the highest level of regulatory control, including pre-market approval (PMA), which requires evidence providing a reasonable assurance of the device's safety and effectiveness [54; 55].