Essential Requirements (Annex I)

The Medical Devices Act is based on the fundamental requirements that medical devices may only be allowed within the European Economic Area if they satisfy the essential requirements (MPG, Article 8 Section 2).

The manufacturer demonstrates the conformity of a medical device with the essential requirements by affixing the CE marking to each individual device (MPG, Article 8 Section 1).

The essential requirements explain the aim of the Medical Devices Act in that they represent a set of criteria. For a medical device to be used in the European market includes the following:

• the safety
• the technical performance and
• the medical performance of a medical device.

The conformity assessment procedure (MPG, Article 14) is used to proof that the safety and technical performance meet their requirements while the medical performance is verified in the context of the clinical assessment.

A device does not necessarily have to satisfy all of the essential requirements, but only those which  are directly connected with the purpose of the device. It is basically left to the manufacturer to decide how to satisfy the essential requirements.