In Australia, however, all medical devices, regardless of their class, must comply with the Australian Regulatory Guidelines for Medical Devices (ARGMD), which include requirements for product design and manufacture, benefits outweighing risks, minimisation of risks and unwanted effects, etc. Despite the implementation of common regulatory frameworks in Europe, each Member State has its own competent authority in charge of managing medical devices. The table below compares the stages of pharmaceutical testing with those of medical devices. To obtain the CE marking, a Class III medical device must only demonstrate safety and performance, not necessarily efficacy.
This does not mean that specific outcomes of medical device functionality, such as device failure, device breakage, device slippage, device migration or screw loosening, etc., are excluded. When a medical device company obtains an IDE to conduct a pivotal study, the focus shifts away from safety and towards collecting data that will be used to justify the safety and efficacy of the product. An IDE for a feasibility study allows the medical device company to conduct a small clinical trial, typically with 10-40 participants. The Food and Drug Administration (FDA) and the EU Medical Device Directive (MDD) only for Class IIb and Class III medical devices (i.e.
for Class I medical devices). Before a medical device company can begin conducting medical device clinical trials, it must determine the types of trials best suited to establish the safety and efficacy of the product. Medical device clinical trials work differently so that simple devices can reach patients more quickly. Sponsors should also be aware of the differences in the regulatory landscape for medical devices in the US.
The most important factor to consider when choosing clinical service providers or a CRO is experience in medical device clinical trials or experience in the field. By definition, a medical device is any "article, instrument, apparatus, appliance or machine used in the prevention, diagnosis or treatment of disease, or for detecting, measuring, restoring, correcting, or modifying the structure or function of the body for any health purpose (World Health Organisation). While approximately 10-15 e of successful 510(k) submissions for Class II devices are based on clinical trial data, Class III devices, the highest risk category, will require extensive medical device clinical trials to establish reasonable certainty of safety and efficacy for the end user. IDE approval is required before medical device companies can conduct a human study using a significant risk product that is not yet approved for its intended use.
One obstacle specifically related to the medical device industry is that there is a lack of a common understanding of the concept of outcomes.