Essential Requirements (Annex I)

The Medical Devices Act is based on the fundamental requirement that medical devices may only be allowed freedom of movement with in 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 which a medical device must fulfil if it is to be freely traded on the European internal market. The essential requirements give particular consideration to

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

The conformity assessment procedure (MPG, Article 14) is used to furnish proof that the requirements concerning safety and technical performance are fulfilled, 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 apply to the device and are directly connected with the purpose of the device. It is basically left to the manufacturer to decide how to satisfy the essential requirements - the important thing is that they are fulfilled.