Looking At The Basics Of The Medical Device Directive

In order to make the medical devices market more coherent between all of its member states, the European Commission published the Medical Device Directive in June 14th, 1993. 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. If you do not know a great deal about medical devices or international treaties then the medical Device directive will seem long and complicated. But, for the member states of the European Commission (EC) the directive simplifies and ensures high quality devices throughout all the territory covered.

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. The function might be concerning diseases and their prevention, diagnosis, treatment or monitoring. They might also be used as a form of contraception. Prosthetic limbs and joints are included in the list of medical devices. When injuries and handicaps occur, the treatment, diagnosis and alleviation of them are medical devices.

You can see in the amount of detail in this definition that the medical device Directive is aimed at making members clear of what is and what is not a medical device.

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. 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. Regular training should be given so that any amendments or add-ons to the directive can be worked into production processes.