On the 14th of June, 1993, the European Commission published the Medical Device Directive in order to create a more streamlined market of medical devices among all of its member states. The number of different pieces of legislation and legalities that could now be overruled so that the market in the territories of the member states was a free one was massive. If you do not know a great deal about medical devices or international treaties then the medical Device directive will seem long and complicated. However, the main gist of it was to simplify, regulate and ensure high quality products were being traded among member states of the European Commission (EC).

The EC listed several articles that would help medical device manufacturers to comply with the new directive and there were two which had the aim of clearing up any discrepancies between definitions and what was actually deemed to be a medical device.

Article 1 described a medical device as something which was an instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application which would perform one of a number of functions. These might be to treat, diagnose or prevent a disease. Also included are devices used in the control of contraception. Limbs and joints that replace natural parts of the body are also medical devices. As are any pieces of equipment used in the diagnosis, treatment alleviation or compensation of injuries and handicaps.

From this detailed definition you can see that the Medical Device Directive wants to clearly state what is a medical device and what is not.

The EC passed the directive as a group of member states, however like all groups of powerful countries, there were differences between some members and others. In order to surpass this difficulty, Article 4 of the directive stipulates that no member state can put obstacles in the way of a device entering the health market in their territory if it has been passed by the EC as a whole. But all devices have to have the CE mark of conformity on them otherwise they are not permitted.

Manufacturers who supply devices into the nations who are members of the EC or who produce devices from within one of the countries will need training on the Medical Device Directive on an annual basis. Regular training should be given so that any amendments or add-ons to the directive can be worked into production processes.

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