Good Clinical Practice for Medical Device Trials
Background
The medical device manufacturing industry is becoming a major player in health-care
delivery. Physicians treat many illnesses and conditions, such as cardiovascular and
neurological diseases, with medical devices as often as with medicine. In 2008, for the
first time, the FDA received more reports of adverse events from these devices than from
pharmaceuticals.
Medical device manufacturers can conduct clinical trials more easily in Europe where
currently regulatory barriers to clinical testing have less constraints. Consequently, new
innovative medical devices typically come to market in Europe first. Approval for
marketing these devices in the US follows in five to ten years, then an additional five to
ten years for Japan, which has the longest regulatory pathway.
A medical device clinical trial can cost between $5 and $10 million in the United States
or Western Europe and more in Japan. The cost of the same trial conducted in Eastern
Europe will be considerably lower, and in India, China, or Korea, it may be 1/10 as
expensive. Manufacturers are turning to Asian countries for their high-risk, first-in-
human studies and even for their pivotal studies because these countries contain a huge
available human population with limited alternatives for healthcare. Also, the regulatory
barrier to starting a device clinical trial in India, China, or Korea is almost nonexistent.
Problem
Regulations for conducting medical device clinical trials around the world have varied
widely. Complications that arise between trials conducted under different protocols make
bringing a device to market difficult in a stricter country. Data may be considered
questionable given different requirements. The time required to determine acceptability
and perhaps repeat trials may delay the device’s approval, frustrating patients as well as
manufacturers. In addition, the safety of human subjects participating in the clinical trial
and ultimately patients is in question in countries with lax regulations and resultant
uncontrolled clinical settings. Less rigorous studies cannot ensure consistent performance
quality thus potentially jeopardizing the health the devices are meant to protect.
Standards to harmonize these trials will ensure safety, effectiveness/performance, and
quality, as well as help to promote commerce, and may ultimately ease suffering.
Approach
In 1993, the European Committee for Standardization (Comité Europeen de
Normalisation, CEN) published standard EN 540, a precursor of the international
standard ISO 14155. Like the International Organization for Standardization (ISO), CEN
is an international nonprofit organization providing a platform for cooperating, volunteer
organizations to develop consensus standards. In 1996, ISO and CEN joined forces to
create the first version of ISO 14155, which repeated EN 540 standards. Almost
immediately, the two organizations formed parallel working groups (WGs) to expand the
standard. WG4 of ISO’s TC (technical committee) 194 developed more elaborate general
requirements in ISO 14155 part 1, while CEN’s WG elaborated part 2, requirements for