Aug 29, 2014

Labeling is the information supplied by the medical device manufacturer, including the label (on the device and packaging) and the data in the Instructions for Use (IFU), as well as marketing materials. While discussions and debate ensued regarding the comment from the Medical Devices Directive MDD 93/42/EEC, Annex I Essential Requirements (ER) that the IFU must be "set out in the leaflet supplied," e-labeling became more accepted with in vitro diagnostic medical devices following the publication of a guidance document in January 2007. Directive 2007/47/EC was published in the fall of 2007, opening the opportunity for e-labeling (albeit a small calculated opportunity, described further below).

The European Commission formed an ad hoc e-labeling expert group that met twice in 2008, and in the fall of 2008, the standard EN 1041:2008 auspiciously heralded e-labeling.

IVD Guidance MEDDEV 2.14.3

The Medical Device Expert Group published MEDDEV 2.14.3, Rev. 1, titled "Supply of IFU and Other Information for IVD Medical Devices," in order to "advise manufacturers on how to provide IFUs and other information" possibly in a "format other than paper" or "through different means of supply." While the guideline isn't legally binding, it is the European Union's first foray into medical device e-labeling. Different media are defined as a format other than paper, such as CD-ROM or DVD, and different means of supply is the concept of providing the IFU through a leaflet or other published material with the device. Examples might include the sales force that would distribute the IFU provision by fax or via the Internet.

Recall that the In Vitro Diagnostic Devices Directive IVDD 98/79/EC, does not use "leaflet" in the ER. Further, the MEDDEV only is to be considered for in vitro diagnostic medical devices for professional users.

Self-test in vitro diagnostic medical devices still must include IFUs in paper format with the device, as well as in vitro diagnostics intended for use at point-of-care facilities.

If you're thinking that the IFUs for professional-use in vitro diagnostic medical devices easily can be provided by different media and by different means of supply-think again.

There are nine conditions that must be met. In particular, when the IFU is available in a non-paper form, there must be a free-of-charge contact phone number. This is to provide the professional user an easy means to request the IFU via fax, mail (the old-fashioned postal service) or e-mail. To make it even more difficult, note that one free contact number that functions in all member European Union states is virtually impossible.

Directive 2007/47/EC Amends the MDD 93/42/EEC

One of the recitals (preliminary introductory material with no inde-pendent legal value) in Directive 2007/ 47/EC, states that a process should be provided to permit manufacturer-supplied information "to be available by other means." Directive 2007/47/EC modified Article 11 to include paragraph 14, which expounded that the process to amend the MDD 93/42/EEC to permit information supplied by other means, would be in accordance within the regulatory frame-work of comitology ("regulatory procedure with scrutiny," Decision 1999/468/EC as amended by Decision 2006/512/EC).

Comitology refers to the committee system that oversees the delegated acts implemented by the European Commission. So, in this case, a committee composed of member state representatives and chaired by a European Commission representative would review draft European Commission measures on e-labeling. If the committee agreed, the draft measures would be shared with the European Parliament and Council.

Provided there was no opposition by the European Parliament or Council, the European Commission would adopt the e-labeling measures.

The European Commission e-labeling ad hoc group met in March and October 2008. While it was discussed that the comitology procedure would be the process used to implement e-labeling, the group curiously is not scheduled to meet in 2009.

EN 1041:2008

With the exception of the information described in this paragraph, EN 1041, Information supplied by the manufacturer of medical devices, was revised based on a mandate given to the European Committee for Standardization by the European Commission. Alternative labeling is described as "any form of electronically accessible information (CD/DVD-ROM, Internet or other mode)."

Annex B provides guidance on medical device IFUs in an electronic format. The annex provides four questions that the manufacturer should consider in its risk assessment prior to supplying this information by alternative means. Once again, alternate mechanisms of supply only are advisable for medical devices for professional users. Further, the format of this information should be indicated on or with the package of the device. And the caveat is that, if requested, a paper IFU should be provided promptly and free of charge.


  • Stewart Eisenhart