SIST EN 1041:2008/kFprA1:2013

Information supplied by the manufacturer of medical devices

This 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 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 a presumption of conformity with the relevant Essential Requirements regarding information to be supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).

Bereitstellung von Informationen durch den Hersteller von Medizinprodukten

Informations fournies par le fabricant de dispositifs médicaux

Informacije, ki jih proizvajalec priloži medicinskim pripomočkom - Dopolnilo A1

General Information

• Status: Not Published
• Public Enquiry End Date: 14-Apr-2013
• ICS: 01.110 - Technical product documentation
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 10-Oct-2013
• Due Date: 15-Oct-2013
• Completion Date: 10-Oct-2013
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 1041:2008/FprA1 - Information supplied by the manufacturer of medical devices

Relations

• Consolidated By: SIST EN 1041:2008+A1:2013 - Information supplied by the manufacturer of medical devices
• Effective Date: 01-Dec-2013
• Amends: SIST EN 1041:2008 - Information supplied by the manufacturer with medical devices
• Effective Date: 01-Mar-2013

Overview

SIST EN 1041:2008/kFprA1:2013 is a European standard developed by CEN that specifies the requirements for information supplied by manufacturers of medical devices. It specifically addresses devices regulated under Council Directive 90/385/EEC for active implantable medical devices and Council Directive 93/42/EEC for medical devices. This standard provides guidance on how manufacturers can meet the essential information requirements stipulated in these directives, offering a presumption of conformity when followed correctly. However, it excludes in vitro diagnostic medical devices, which are covered under separate standards.

Key Topics

• Manufacturer Information Requirements: The standard mandates that information accompanying medical devices must include the name or trade name and address of the manufacturer. Where a manufacturer has no registered place of business within the EU, the authorized representative’s name and address must also be provided.
• Labeling and Instructions for Use: For devices governed by the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD), the manufacturer’s and authorized representative's details must be present on the label, packaging, and instructions for use.
• Use of Symbols and Colours: Symbols and safety-related identification colours employed in medical device information must be clearly explained unless they derive from harmonized standards. This simplifies user comprehension and supports safety.
• Address Format Requirements: The standard outlines detailed elements for the address of the manufacturer and authorized representative, including street, number, postal code, city, region, and country. Exceptions apply if a corporate postal code fully replaces certain address elements.
• Compliance Guidance: EN 1041 guides manufacturers on how to conform to the essential requirements related to information without specifying the language or delivery method of the information. It acts as a complement to the EU Directives, not a replacement.
• Future Revisions: The document notes planned full revisions to address discrepancies between this standard and the legal requirements of the medical device directives. Until then, direct application of directive requirements is recommended.

Applications

SIST EN 1041:2008/kFprA1:2013 is essential for:

• Medical Device Manufacturers: To ensure accurate, compliant, and clear information accompanies medical devices placed on the EU market.
• Authorized Representatives: To meet labeling and information requirements especially when the manufacturer is outside the EU.
• Regulatory Compliance Teams: To verify that product information fulfills EU directives concerning medical device safety and traceability.
• Quality Management Systems: As part of documentation and labeling procedures to support conformity assessments and audits.
• Risk Management and Clinical Use: Clear manufacturer information and explanation of symbols contribute to safe and effective use of medical devices by healthcare professionals and patients.

Related Standards

• EN ISO 15223-1: Specifies symbols to be used with medical device labels, labelling, and information supplied, supporting standardized communication.
• EN ISO 13485: Specifies requirements for quality management systems specific to medical devices, under which EN 1041 requirements often operate.
• EN 980: Defines symbols for use in the labeling of medical devices, referenced for graphical communication in medical device information.
• EU Council Directive 90/385/EEC: Relates to active implantable medical devices and their information requirements.
• EU Council Directive 93/42/EEC: Governs medical devices including labeling and information supply criteria.

Adhering to SIST EN 1041:2008/kFprA1:2013 helps manufacturers ensure that medical devices marketed in the EU comply with essential informational requirements, thereby facilitating regulatory approval, user safety, and device traceability.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2013
,QIRUPDFLMHNLMLKSURL]YDMDOHFSULORåLPHGLFLQVNLPSULSRPRþNRP
Information supplied by the manufacturer of medical devices
Bereitstellung von Informationen durch den Hersteller von Medizinprodukten
Informations fournies par le fabricant de dispositifs médicaux
Ta slovenski standard je istoveten z: EN 1041:2008/FprA1
ICS:
01.110 7HKQLþQDGRNXPHQWDFLMD]D Technical product
L]GHONH documentation
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
FINAL DRAFT
EN 1041:2008
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA1
January 2013
ICS 01.110; 11.040.01; 11.120.01

English version
Information supplied by the manufacturer of medical devices
Informations fournies par le fabricant de dispositifs Bereitstellung von Informationen durch den Hersteller von
médicaux Medizinprodukten
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/CLC/TC 3.
This draft amendment A1, if approved, will modify the European Standard EN 1041:2008. If this draft becomes an amendment, CEN and
CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant national standard without any alteration.

This draft amendment was established by CEN and CENELEC in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-
CENELEC Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.

CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2013 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN 1041:2008/FprA1:2013 E
worldwide for CEN national Members and for CENELEC
Members.
Contents Page
Foreword . 3
1 Modifications to Clause 2 . 4
2 Modification to 4.2 . 4
3 Modification to 5.1 . 4
4 Modifications to the Bibliography . 5

Foreword
This document (EN 1041:2008/FprA1:2013) has been prepared by Technical Committee CEN/CLC/TC 3
“Quality management and corresponding general aspects for medical devices”, the secretariat of which is held
by NEN.
This document is currently submitted to the Unique Acceptance Procedure.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directives.
For relationship with EU Directives, see informative Annex ZA and ZB, which are integral parts of this
document.
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