Document Center’s Medical Device customers frequently use the BS EN 1041, “Information supplied by the manufacturer of medical devices.” So we’ve had a great deal of interest in the recently released edition which includes the new A1 Amendment. This official English language edition of the EN 1041 includes both the 2008 Edition and the recent Amendment 1 approved by CEN in July 2013. Adoption of the standard within Europe must be accomplished by March 2014.
The amendment has made a number of changes to the EN 1041 document, all of which are clearly marked in the BS adoption document. References to the EN 980 have been removed, since that document has been cancelled and replaced by BS EN ISO 15223-1.
Users of the standard will want to review the modified Section 5.1 on General Requirements with care. It is now divided into two parts: 5.1.1, Safe and effective use of the device, and 5.1.2, Address required under medical devices directives. The trade name and address information for the manufacturer has been greatly expanded.
Footnote information has been added in section 2, Normative references (referenced documents for you American readers), and Section A.2 of Annex A. There is also a brief addition to section 4.2 on Units, symbols and colours (colors).
However, there is a 2 paragraph addition to both Annex ZA and ZB. This new material addresses some of the recent issues that have arisen since the release of the Annex A material in 2008. FYI: Annex A needs to be reviewed by each medical device manufacturer to make sure that the European legal requirements are fulfilled.
The issuing committee has become concerned that the information in the 2 Z Annexes is not complete — that is, that some of the material in Annex A should be included in the ZA and ZB Annexes. They also realized they needed to resolve a number of discrepancies between EN 1041’s Annex A and the actual medical device directives’ Annexes as well.
While this amendment does make some corrections, a full revision of the standard is underway. But the committee does warn the user that in the case of this standard, the requirements of the directives (93/42/EEC and 90/385/EC) need to be applied directly to your device. Compliance with the EN 1041 standard may not be enough to assure compliance with European regulation.
As a final note, both the EN 980 and the EN ISO 15223-1 have been added to the Bibliography.
To purchase your copy of the amended EN 1041, go to the Document Center webstore, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re here to help you use and maintain your standards, providing you with in depth information for improved decision making and compliance. Make us your Standards Experts!
