This file BS EN 1041:2008+A1:2013 is free to download.
Name:Information supplied by the manufacturer of medical devices
Format:PDF
Size:2.48M

Introduction

The first edition of this standard was drafted in a period when the Active Implantable Medical Device Directive (AIMDD)(90/385/EEC) and the Medical Device Directive (MDD)(93/42/EEC) were relatively new and the In Vitro Diagnostic Medical Device Directive(IVDD)(98/79/EEC)was not in existence. In addition, at the time the previous edition of this standard was adopted, the established method of providing information on, with, or otherwise in association with a device was by hard copy. Predominantly, this was printed copy on substrates such as paper,card, or plastic.

This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It doesnot specify the language to be used for such information,nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption ofconformity with the relevant Essential Requirements regarding information to be supplied.

Download here:BS EN 1041:2008+A1:2013