Harmonized standards are European Norms (EN).
The EU standards and the Medical Device Directive define the basic requirements concerning the safety of medical devices.
The General Requirements lays down basic principles of the safety and effectiveness of a medical device in a general way. The manufacturer shall determine suitable technical requirements of its medical device to demonstrate the conformity. The technical specification is carried out within harmonized standards. European Union provides a list of harmonized Standards for medical device manufacturer reference.
Harmonized standards are European Norms (EN) that are elaborated by the European standardization bodies (CEN, CENELEC, ETSI) under a mandate from the European Commission. The Commission specifies certain essential requirements within a given directive that have to be set out in greater detail.
If there is no applicable for a medical device or a feature of a medical device, manufacturers are advised to use applicable International Standards such as EN, CEN, ISO or IEC standards. National Standards may be used when necessary. Notified Bodies verify the appropriateness of the standards used when conducting evaluation.
Lists of harmonized standards related to the medical directives:
The use of European Harmonized Standards is voluntary.
However, conformity of EU Harmonized Standard is deemed to satisfy the applicable General Requirements.