Medical Products

What Do You Know About The Medical Device Directive?

The Medical Device Directive was first published on June 14th 1993 by the European Commission as a way to streamline the medical device market among its member states. In order to establish a free market of medical devices among all member states, there was a huge amount of legislation and regulations which needed to be synthesized. You may be confused by the amount of technical wording in the Medical Device Directive if you do not have a thorough knowledge of medical devices or treaties. 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).

There are many articles in the directive which aim at helping manufacturers to comply with this multi-national treaty two of which clear up just what a medical device is and how it should be marketed.

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. Prosthetic limbs and joints are also considered to be medical devices. Under the directive, any device used in the treatment, diagnosis and alleviation of injury and handicaps is included.

And so from this detailed definition you can see that the Medical Device Directive has tried to clear up what is and what is not considered to be a device.

Some of the members of the EC were not as enthusiastic as others over the directive even though it was passed by them all. Article 4 of the directive is aimed at overcoming these problems by stating that no member can place any obstacles in the way of a medical device being used in their territory that has been passed by the EC. however no device without the CE mark of conformity can be used an EC member state.

Manufacturers of devices who supply or make products in the territory of EC member states need training on the Medical Device Directive so that they can conform with the regulations. This is because there are amendments and annexes attached to the directive when something large occurs in the device industry and manufacturers will need to be aware of how the changes affect their processes.

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