BS EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices

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BS EN 1041:2008+A1:2013

Information supplied by the manufacturer of medical devices

Status : Current   Published : August 2008



BS EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices

The first edition of BS EN 1041 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.

Since the time of approval of the first edition of this standard on 18 January 1998, the MDD and AIMDD have been amended. In addition, other methods of provision of information have become freely available and widely used. The intention of this second edition is to make available guidance for manufacturers of medical devices that is appropriate regardless of the means used to disseminate that information as well as to update the requirements to reflect the changes to Directives 90/385/EEC and 93/42/EEC.

BS EN 1041, Directives 90/385/EEC and 93/42/EEC refer to the versions amended in 2007. The guidance reflects the desire to take into account different methods of provision of information, and it is intended that it should, as far as possible, be suitable for future methods of provision of information.

The requirements and guidance will provide manufacturers with appropriate means to ensure that their provision of information is relevant to all intended recipients and is in compliance with the Essential Requirements of the Directives. The requirements may also provide means by which compliance can be tested by regulatory and inspection agencies. The possibility of providing information by alternative means is foreseen in Directives 93/42/EEC and 90/385/EEC.

BS EN 1041:2008+A1:2013 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 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. 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.


Standard NumberBS EN 1041:2008+A1:2013
TitleInformation supplied by the manufacturer of medical devices
Publication Date29 August 2008
Cross ReferencesEN ISO 3166-1, ISO 3166-1:2006, ISO 639-1, ISO 1000, ISO 8601, CEN/TR 15133, EN 375, EN 376, EN 556-1, EN 556-2, EN 591, EN 592, EN ISO 780, EN ISO 13485, ISO 13485:2003, ISO 7000, 98/79/EC, 89/617/EEC, 2004/108/EC, 93/465/EEC, 89/618/Euratom, 80/181/EEC, 90/385/EEC, 93/42/EEC, EN ISO 14971, ISO 14971:2007, EN ISO 15225, ISO 15225:2000, EN ISO 17664, ISO 17664:2004, EN 980, EN ISO 15223-1
ReplacesBS EN 1041:1998
International RelationshipsEN 1041:2008
Amended ByAmendment, October 2013. Amends and replaces BS EN 1041:2008.
Draft Superseded By06/30123163 DC13/30272487 DC
DescriptorsMedical equipment, Implants (surgical), Medical instruments, Technical documents, Instructions for use, Handbooks, Documents, Marking, Identification methods, Packaging, Sterile equipment, Definitions, Consumer-supplier relations, Symbols, Safety measures, Hazards
Title in FrenchInformations fournies par le fabricant de dispositifs médicaux
Title in GermanBereitstellung von Informationen durch den Hersteller von Medizinprodukten
ISBN978 0 580 80873 9
File Size561 KB

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