New list of harmonised standards for Medical Devices
The only thing that is constant is change. This also applies to the EU regulatory system. Staying informed about the latest changes in harmonised standards is important for manufacturers, because these standards specify the basic requirements that Medical Devices must fulfill under the EU directives and the Medical Devices Act. The new list of harmonised standards on the EU website provides an overview of the most recent changes that have come into effect in January 2013.
Compliance with the relevant harmonised standards provides a presumption of conformity, i.e. the device is deemed to satisfy the relevant essential requirements of the directives. However, not all requirements have been specified in harmonised standards. In those cases, for example, national standards can be used. The harmonised standards are developed by international standards organisations (CEC, ISO), transformed into European standards by the European standards organisations (CEN, CENELEC) and then transposed into national standards. The standards and their ongoing amendments come into effect upon publication in the Official Journal of the European Union (OJEU). Since July 1, 2013, both the print and electronic edition are legally binding.
The EU regularly publishes a summarised list of harmonised standards. This list was last published in January 2013 with the following changes:
New lists of harmonised standards related to the following directives