chapter  21
26 Pages

The Medical Devices Directives Requirements and

Each manufacturer must obtain conformity certifications for the device.

Each manufacturer must establish a Declaration of Conformity.

Each manufacturer must apply for the CE mark.

21.2 Compliance

21.2.1 Choosing the Appropriate Directive

Because of the diversity of current national medical device regulations, the European Commission decided that totally new Community legislation covering all medical devices was needed. Software or a medical device containing software may be subject to the requirements of the Active Implantable Medical Devices Directive or the Medical Devices Directive.