Healthcare Technologies Resource Guide - Export.gov

European Union
Summary
As the European Union (EU) does not have a Food and Drugs Administration
(FDA), the task of harmonizing requirements and regulating medical devices
is handled by the European Commission in close cooperation with Member
State’s Health Authorities. The purpose of the EU harmonization effort is to
merge the differing national requirements into one law which can be applied
throughout the European Union. Legislation adopted through this process
covers implantable, non-implantable and in vitro diagnostics medical devices in
three separate directives that provide manufacturers the basics to certify their
compliance with EU-wide safety requirements.
Adopted Legislation
The following EU directives are in force throughout the European Union
consisting of 27 Member States (Austria, Belgium, Czech Republic, Cyprus,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy,
Latvia, Lithuania, Luxemburg, Malta, the Netherlands, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Romania, Bulgaria and the United Kingdom):
• Active implantable medical devices (90/385/EEC): Active implantable
medical devices (AIMD), such as heart pacemakers or defibrillators are
defined as “any active medical device which is intended to be totally or
partially introduced, surgically or medically, into the human body or by
medical intervention into a natural orifice, and which is intended to remain
after the procedure.” Considering the potentially high risk factor of such
devices for the patient, manufacturers cannot self-certify and have to rely
on the services of an accredited test laboratory to complete the process of
compliance.
• Medical devices (93/42/EEC): Medical devices are broadly defined as “any
instrument, apparatus, appliance, material or other article, whether used
alone or in combination, including the software necessary for its proper
application intended by the manufacturer to be used for human beings”
for several purposes such as diagnosis, treatment, alleviation of disease
and more. As the range of this directive is broad and leaves room for
interpretation, the Commission has written guidance for manufacturers.
Medical devices include syringes, bandages, wheelchairs, endoscopes,
prescription glasses and contact lens solution among others. As the
range of devices covers minimal risk as well as higher risk devices, the
classification of the product will determine whether a manufacturer can
self-certify or needs to involve the services of an accredited test laboratory.
• In vitro medical devices (98/79/EC): An in vitro diagnostic device (IVD)
is a “reagent, reagent product, calibrator, control material, kit, instrument,
apparatus, equipment or system whether used alone or in combination
intended by the manufacturer to be used in vitro for the examination
of specimens, including blood and tissue donations, derived from the
Statistics
Capital: Brussels, Belgium
Population: 501,259,840
GDP: USD 14.793 trillion
Currency: Euro (€)
U.S. Commercial Service Healthcare Technologies Resource Guide | 2012–2013
Contact
Sylvia Mohr
Commercial Specialist
sylvia.mohr@trade.gov
(32-2) 811-5001
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