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The Centre for the Promotion of Imports from developing countries (CBI) was established in 1971.

CBI is an Agency of the Ministry of Foreign Affairs and part of the development cooperation effort of The Netherlands.

CBI contributes to the equitable economic development of selected developing counties by providing export marketing and management support to their SME exporters and Business Support Organizations with the purpose of increasing exports to Europe.

From survey to success Guidelines for exporting medical devices and disposables to the EU

Publication date: November, 2008
These guidelines were compiled for CBI by CREM
Disclaimer CBI market information tools:


Are you already exporting to the EU, but do you want to enlarge your exports to the EU? Or, if you are not yet exporting to the EU, should your company start exporting to the EU?

Which (new) target market(s) should you aim for and which key product(s) should you choose? Which trade channel fits your company best and how do you promote yourselves to EU buyers? These are common concerns of exporters from developing countries (DC) who want to enlarge their exports to the EU or who consider to start exporting to the EU but are not sure if it is right for them. That is what these export guidelines are all about: to help you to evaluate whether or not to get involved in the EU market or how to improve your approach of the EU market.

From survey to success: these guidelines are a practical add-on to the CBI market surveys for the medical devices and disposables. If you did not yet consult the CBI market survey ‘The medical devices and disposables market in the EU’, you are advised to do so before continuing with these guidelines. These guidelines are adapted to the specific challenges in the medical devices and disposables industry and contain many practical suggestions which will help you in making decisions.

First, you are advised to define whether your company is ready to export or not. Chapter 1 helps you answering this question. Then, if the answer to this question is positive, it is time to prioritise. Chapter 2 guides you through a process of country- and product selection, which helps you to focus your export efforts. Once you have defined a target country in the EU and some priority products, you will have to choose the right entry strategy and the appropriate sales channel. Chapter 3 deals with this sales channel assessment. Chapter 4 gives you a range of practical suggestions for your marketing tools and chapter 5 discusses the financial part of exporting.

These guidelines are an addition to related CBI information that covers the general theory of exporting, like the CBI export manual ‘Export Planner’ and the CBI export tool ‘EMP Builder’. The market surveys, export manuals and export tools are available at

Although these guidelines are developed in particular for exporters, also Business Support Organisations (BSOs) could very well make use of it. Staff of BSOs in DC can use this document to support and advise their members about exporting to the EU.

1. Export: Yes or no?

As can be read in the CBI market survey ‘The medical devices and disposables market in the EU’, exporters from DC have several opportunities to enter the EU market; especially since producers from DC are now able to offer good quality and low-cost medical devices and disposables. However, there are some important requirements that DC have to meet before they are able to export successfully to the EU on the long term. If your company is not able to meet those requirements or is not able to overcome these challenges in the near future, it is not advisable to start exporting to the EU. DC exporters should be prepared (at least initially) to:

Comply with European market access requirements

Fulfilling European legislative requirements is compulsory for all products traded within the EU. An exporter in a DC must comply with the legislative requirements that are applicable to an exporter’s product. For example, when wishing to import a specific medical device in European legislation there are three directives that may apply and they include:

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