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.
The Medical Devices Complete CE Documents Kit contains all documents that you need to get started with the CE Marking of medical devices:
1. Consolidated text of the Medical Devices Directive 93/42/EEC. Consolidated means that all current amendments have been included in the text, including the latest amendments to the Medical Devices Directive introduced by the Directive 2007/47/EC. Now you no longer have to go through 5 different documents to find out what applies! The text of the Directive is made available for download immediately after your order.
2. Not less then 34 (!) official guidelines on various issues related to the Medical Devices Directive. The guidelines are related to topic like scope, field of application, definitions, essential requirements, conformity assessment procedures, clinical studies, Notified Bodies, market surveillance, in vitro diagnostics and others.
3. A editable template of the Declaration of Conformity in MS Word format (immediate available for download upon order).
4. A set of graphical files of the CE Marking Logo (immediate available for download upon order).
No need to waste any more time on finding the right documents for the CE Marking of medical devices.
