European Device Regulatory Revolution: A Personal View
REGULATIONS AND STANDARDS
Manufacturers entering the European medical device market in recent years may not be aware of the
complexities of trying to achieve this objective 20 years ago. Significant progress has been made, although
much remains to be done. This article provides a personal view of the innovative approach to medical
device regulation introduced in Europe in the early 1990s.
No two systems alike
Before the introduction of the medical device directives nearly 20
years ago, European regulation of medical devices was a patchwork
of differing requirements. No two countries had the same system for
regulating medical devices. Some countries had published regulations for certain types of medical products, such as sterile medical
devices; others maintained lists of devices that were regulated based
on perceived risk or national experience; certain countries classified some devices as medicinal products while subjecting others to
specific device regulations. In yet other countries, medical devices
were not subject to a regulatory regime or were regulated under voluntary systems of control. These differences represented a significant
barrier to trade, which also affected other industrial sectors.
At that time, many will agree that the strongest point of reference
for a comprehensive system of regulating medical devices rested
with the United States (US) Food and Drug Administration (FDA).
The US Medical Device Amendments of 1976 and the establishment of the Bureau of Medical Devices, later merged with the
Bureau of Radiological Health to become the Center for Devices
and Radiological Health, allowed FDA to provide a specific set of
requirements for medical devices, which differed in important ways
from the manner in which it regulated pharmaceuticals and other
products.
The US system was certainly known to European regulators.
I am aware of regulators in one European country that carefully
studied FDA’s approach to medical device regulation and compared
it with their approach, which had been defined in a national law
published in 1986. Subsequently, the European Commission pressured countries to stop the development of their own systems for
regulating medical devices, because European harmonisation efforts
were underway. Other contacts between the United States and
Dr Maria E. Donawa
physician, pathologist and pharmacist with nearly 30 years’
regulatory experience, worked with the US FDA before becoming
President of what is now Donawa Lifescience Consulting,
Europe included the Tripartite Subcommittee for Medical Devices,
which fostered a mutual awareness of US and UK device regulatory
systems. The Tripartite Subcommittee consisted of senior officials of
the medical device authorities of the United States, United Kingdom
and Canada and produced through its Toxicology Subgroup, the
Tripartite Biocompatibility Guidance for Medical Devices of 1987,
to which FDA still refers today. In spite of this close contact, Europe
chose to adopt a system for regulating medical devices that differed in significant ways from the United States or other regulatory
regimes.
An innovative approach
As a result of considerable effort by a number of interested parties, including industry segments, medical devices were included in
the products covered by Europe's “New Approach” to technical
harmonisation. This approach, introduced by a European Council
resolution in 1985, addressed a persistent and frustrating problem in
Europe unofficially termed Eurosclerosis. This unfortunate condition
meant that by the time European directives containing very detailed
technical provisions were adopted, they were already obsolete.
To counter this, the New Approach directives referenced a list of
essential requirements that become legally binding when transposed
into national laws and regulations. The detailed technical provisions
are provided in harmonised standards adopted and updated by
European standards organisations CEN and CENELEC. Although
these standards are voluntary, they confer a presumption of conformity with the relevant essential requirements. Products that are in
compliance with the directives are then able to circulate throughout
the European Economic Area.
The medical device directives are New Approach directives.
Image: iStockphoto
The Active Implantable Medical Devices Directive (90/385/EEC)
a full service European CRO and an international consultancy company,
which provides regulatory, quality and European Authorised Representative
services to life science companies.
