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New references of harmonised standards on medical devices, active implantable medical devices, in vitro diagnostic medical devices, radio equipment and pressure equipment published

New references of harmonised standards on medical devices, active implantable medical devices, in vitro diagnostic medical devices, radio equipment and pressure equipment published
Published on: 17/11/2017

The updated lists of references of harmonised standards were published today in the Official Journal of the European Union (C389, 17 November 2017) in support of Directive 93/42/EEC on medical devices (10 new references), Directive 90/385/EEC on active implantable medical devices (2 new references),  Directive 98/79/EC on in vitro diagnostic medical devices (3 new references), Directive 2014/53/EU on radio equipment (5 new references) and Directive 2014/68/EU on pressure equipment (20 new references).

In certain EU harmonisation legislation for products, voluntary harmonised standards, developed by the European standardisation organisations (CEN, Cenelec and ETSI), may be used by manufacturers to demonstrate compliance of their products with applicable essential requirements.

Such harmonised standards confer a presumption of conformity with legally binding requirements after the European Commission has published their references in the Official Journal (OJ).

The publication of the references of harmonised standards in the OJ does not prevent manufacturers from applying any other technical solution or undergoing the alternative conformity assessment procedures provided for in the sectoral legislation to demonstrate the compliance of their products.

There are over 30 EU directives or regulations where harmonised standards can be used as a means to demonstrate compliance with EU legislation. The Commission frequently updates the lists of references of harmonised standards and new references are usually published in the OJ on the second Friday of each month.

Lists of references are published in the OJ but the Harmonised Standards webpage gives easy access to all the latest references.

Updated lists of references: