Harmonized CEN standards

Harmonized CEN Standards are standards based on the guidelines of the Council of Europe. The preparation of these standards was requested by the European Commission from the appropriate CEN committees. These standards are drawn up by the European standards institutions CEN/CENELEC together with the national standards institutions, and are published by the European Commission in the Official Journal of the European Communities as harmonized standards. These standards are then converted into national standards, and are denominated as the Harmonized Standards (e.g. DIN-EN). 

These standards specify the legal requirements placed on the products, procedures (e.g. clinical testing, surveillance), institutions and persons. However, the compliance with the standards is of a voluntary character. For instance, 6 MPG says The adherence to the provisions of this act is expected for those medical products which correspond to the harmonized standards concerning the appropriate medical products.  

The harmonized standards are therefore not legally binding, and have only a voluntary character for the user. They are based on presumptions which may be vitiated. However, the manufacturers who deviate from the rules set by these standards have to be ready to prove that safety level of their produets is as high as it would have been, had the rules set by the harmonized standards been honored. 

The ISO-Standards are produced by the commissions of the International Organization for Standardization for the worldwide use. They also have a voluntary character for the users but may also be referred to by courts in order to assess the safety level of the products or the processes in question. 

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