What is this standard about?
It exists to help medical device manufacturers comply with the information requirements of the European medical device directives.
Who is this standard for?
Manufacturers of medical devices
Why should you use this standard?
It specifies requirements for information to be supplied by manufacturers of 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 does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied.
The standard is also intended to complement the specific requirements of the cited EU Directives by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.
What’s changed since the last update?
This first amendment to BS EN 1041:2008 implements CEN/CENCELC amendment A1:2013. The principal changes are the addition of clauses on the provision of information on the safe and effective use of the device (5.1.1) and on the format and location of the manufacturer’s name and address as required by the medical devices directives (5.1.2).
