List European Harmonized Standards for the Medical Devices Directives (93/42/EEC, 90/385/EEC, and 98/79/EC) Updated

On Friday 27 April 2012, the European Commission published updated lists of the European harmonized standards that pertain to the Medical Devices Directive (93/42/EC), In Vitro Diagnostics Directive (98/79/EC), and the Active Implantable Medical Devices Directive (90/385/EEC). The standards on these lists may be used by manufacturers to prove that their equipment complies with the essential requirements of this directive. The updated list are important to all manufacturers of CE marked medical devices, active implantable medical devices and in vitro diagnostics that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directives, re-evaluate your products against the updated standards and update your Declaration of Conformity.

Medical Devices CE Documentation Kit

Looking for CE Marking a medical device? The process starts with reading the Medical Devices Directive (93/42/EC) and by applying the requirements written there. This can be a tedious process, because the text of the Medical Devices Directive has been amended several times. For your convenience we have a compiled a kit of important documents that you require in order to CE Mark medical devices.

Are your CE marked medical devices up to date with the latest standards?

The European Commission published updated lists of European harmonized standards for the medical devices directives (Medical Devices Directive, Active Implantable Medical Devices Directive and In Vitro Diagnostics Directive). Manufacturers of CE marked medical devices should check if the European harmonized standards that they have used during the conformity assessment are still valid, or whether they have been updated by these lists.