TS EN 1041+A1

TS EN 1041+A1 addresses how information supplied by medical device manufacturers should be organised and presented. It focuses on the information that accompanies active implantable medical devices and general medical devices, creating a common technical framework for manufacturer-supplied content such as labelling, instructions for use, warnings, and related information.

Scope and boundaries of the document

The standard does not prescribe the language to be used, nor does it define the exact medium or delivery method for that information. Instead, it provides guidance on means by which certain essential requirements in the EU medical device directives can be met. When a manufacturer follows those means, this provides a presumption of conformity with the relevant Essential Requirements for information supply. That said, the document does not replace national legislation where a country has specified its own method for supplying information.

Why manufacturer information is a distinct technical topic

In general technical practice, the information supplied with a medical device is central to correct identification, safe use, installation, maintenance, and interpretation of the device. Manufacturer information can include intended purpose, limitations, labelling content, and user-facing instructions. The value of this standard is not in prescribing every piece of content, but in establishing a consistent framework for how that information is handled and presented by the manufacturer.

• Applies to information supplied by manufacturers of active implantable and general medical devices.
• Does not define the language or the means of communication.
• Supports compliance with relevant Essential Requirements in the EU directives.
• Does not cover information provision for in vitro diagnostic medical devices.