BS EN 1041:2008 Revision to the Medical Devices Directive
A new revision to BS EN 1041:2008 has been released. This Standard specifies the information that must be supplied with each medical device sold in Europe. There are not many significant changes from the previous version of EN 1041 released in 1998. Nonetheless, we have summarized them below.
EN 1041:2008 takes into account the modifications made to the Medical Devices Directive (93/42/EEC) by Directive 2007/47/EC. EN 1041 acknowledges "the desire to take into account different methods of provision of information" and while alternative labeling for medical devices is still being discussed, Annex B includes guidance on alternative labeling.
Some of the changes, additions, deletions, and modifications, noted in EN 1041:2008 include:
- Two additional definitions including a definition of "alternative labeling" - See page 6, Section 3.3
- Clarification that "information supplied by the manufacturer" reference "all material, however provided" - See page 6, Section 3.4
- Deleted comment about size and legibility of labeling "under illumination of 215 1x"
- Manufacturer may use two letter alpha code from ISO 639-1 to represent the names of the language - See page 7, Section 4.3
- Manufacturer may use two letter alpha code from ISO 3166-1 to represent the names of the country - See page 7, Section 4.3
- Most of the guidance previously in Annex C of EN 1041:1998, doesn't change, though it is now included as Annex A.1. - See page 9, Annex A
- One notable guidance, for Annex I, Essential Requirements, 13.3 (a), "address needs to be sufficient to contact the physical location. "The post box alone is not sufficient." - See page 10, Annex A.1
Annex B, guidance on alternative labeling for Instructions for Use (IFU) includes the following changes:
- Examples of alternative labeling are as follows, though not limited to: physical electronic media, CD/DVD-ROMs packaged with the device, "help" systems provided with the device, and information provided over the internet. - See page 19, Annex B
- Four questions are included to query the manufacturer, and for the manufacturer to consider, in their risk assessment (See page 19, Annex B):
- knowledge and experience of user with hardware and software required to display alternative labeling,
- access of user to resources to visualize alternative labeling,
- what issues prevent the alternative labeling from being displayed on the device, for example if there was a device problem, and
- what options exist if labeling is requested as physical labeling?
- Explicit guidance is provided to assist with implementing alternative labeling - See page 20, Annex B.1
- Similar to MEDDEV 2.14.3, Rev. 1 (IFUs IVDs, January 2007), if a user requests a paper copy of the IFU this should be available at no charge and provided promptly. Unlike guidance document MEDDEV 2.14.3, Rev. 1, there is no stipulation that a toll-free telephone number be included for the user to obtain the IFU.
In February 2009, EN 1041:2008 will be given the status of a national Standard. August 2011 is the date by which conflicting national standards must be withdrawn and when BS EN 1041:1998 becomes obsolete.