Draft EU Regulation on e-Labeling of Medical Devices
29 June 2011
The European Commission published, on June 8, a draft regulation on e-labeling as part of their WTO Technical Barriers Trade activities. The draft regulation can be downloaded from the EU website. The proposed date for adoption is 14 December 2011. See the WTO document.
The draft Regulation sets out conditions according to which instructions for use in paper form may be replaced by electronic instructions for use. It limits the possibility of providing instructions for use in electronic form to defined medical devices and accessories intended to be used in specific conditions. Furthermore, it contains a range of procedural safeguards. Thus instructions for use have to be provided in paper form on request, and a specific risk assessment by the manufacturer and information on how to access to the instructions for use is needed.
The draft Regulation also sets up a few basic safety requirements for:
- instructions for use in electronic form which are provided in addition to complete instructions for use in paper form, and
- websites containing such instructions for use.