TS EN 1041

TS EN 1041 is the standard that addresses information supplied by the manufacturer for active implantable medical devices and other medical devices placed under the relevant EU medical-device directives. Its focus is not the device’s clinical performance, but the information that accompanies the device and supports identification, use, installation, and safe operation—such as labeling, instructions for use, and related manufacturer communications. The document does not prescribe the language or the delivery medium for that information; instead, it frames how the information requirements are to be met.

What this standard covers in practice

The standard applies to medical devices regulated by Council Directive 90/385/EEC and Council Directive 93/42/EEC, and it is intended to complement the Essential Requirements on information to be supplied in those directives. In general technical terms, this places emphasis on how manufacturers present product identity, usage guidance, warnings, and other user-facing information in a consistent and understandable way. The document supports the broader documentation process around medical devices rather than defining a single label format or a fixed communication channel.

Boundaries and related vocabulary

• It does not cover information requirements for in vitro diagnostic medical devices; those are handled by other labeling standards.
• It does not specify which language must be used, or by what means the information must be supplied.
• The standard is intended to support conformity with the relevant directive requirements by giving guidance on acceptable means of meeting them.