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CBI EXPORT GUIDELINES
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Active Implantable Medical
Devices (AIMDD)
Directive 90/385/EEC
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Dangerous Substances and
Preparations
Directive 93/21/EEC
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Medical Devices Directive (MDD)
Directive 93/42/EEC
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In Vitro Diagnostic Directive (IVDD)
Directive 98/79/EC
For information on legislation
for medical devices and disposables, go to ‘Search CBI database’ at http://www.cbi.eu/marketinfo,
select your market sector and the EU in the category search, click on the search
button and click on legislative requirements for an overview of all documents on
legislation. It includes additional information on packing, marking, labelling,
and non-legislative requirements as well. Non-legislative requirements, for
example, include social and environmental codes of conduct that are of growing
importance to the European market and to international trade.
Additional information can be
found on the following websites:
Meet industry specific
challenges
The medical devices and
disposables market is a complex industry. Exporters of medical devices, for
example, have significantly different challenges to contend with than exporters
of medical disposables. One of these challenges is dealing with the fierce
competition between suppliers in the EU market and the strong relationships
between suppliers and buyers. It will therefore be important for exporters from
DC to invest in exploring market opportunities and building relationships with
possible trading partners.
In the medical device market DC
exporters are competing with large European manufacturers that invest a lot of
time and money in the research and development of new technologies and
innovative products. In most cases, DC manufacturers will not be able to invest
similar amounts of resources. Moreover, information on the demands and
developments of the European market will be harder to come by without a good
network in the market.
Another specific challenge facing
the medical devices and disposables market in the EU are the restrictive
measures being implemented on health care systems. Governments of EU Member
States are reforming their policies regarding the reimbursement of medical
devices and disposables. Changes in the reimbursement policy will affect the
demand of hospitals and group purchasing organisations for specific products. It
will therefore place special demands on developers and manufacturers.
Because there are big differences
in the reimbursement policies of the various EU Member States it is important to
conduct further research to see where you stand. A good starting point are the
CBI sector surveys covering the market in individual EU countries.
Prepare your company to be
export ready
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Do the Export Readiness Checker
at http://www.cbi.eu/tools ( ‘export checker’);
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Have a first look at the online
exercise to write an Export Marketing Plan (EMP Builder) at http://www.cbi.eu/tools
( ‘Export Marketing Plan’). Familiarize yourselves already with the demands and
requirements of exports;
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CBI’s ‘Export Planner’, in
particular chapter 1 and 2 (http://www.cbi.eu/marketinfo ‘search CBI
publications’ export manuals).
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