On September 23, 2011, the European Commission issued its much awaited draft regulation on Electronic Labeling (e-labeling) for Medical Devices. The draft regulation has been submitted to the Council and the European Parliament which will have three months to provide feedback or accept. The final version is expected to be adopted in December and come into force in March 2013.
The draft regulation, which was initially published for public consultation earlier this year, sets out conditions under which instructions for use may be provided electronically rather than in paper format for medical devices that are exclusively used by professional users. It limits e-labeling to defined medical devices and accessories intended to be used in specific conditions. It also outlines a documented risk assessment that must be performed by the manufacturer which should demonstrate that providing the instructions for use electronically will maintain or improve the level of safety then when providing the instructions for use in paper format. This risk assessment must be updated in view of experience gained in the post market phase.
The regulation includes several safeguards, including manufacturer requirements to have a system in place to provide printed instructions for use upon request at no additional cost to the user. The printed instructions must be received by the requester within the time period set out in the risk assessment, not exceeding seven calendar days. It also clearly outlines the requirements for electronic delivery including that the instructions for use, even when delivered with or within the device electronically, should also be made available through a website. Manufacturer’s websites must adhere to several requirements including user access to all previous versions for use in their electronic form and their date of publication.
When finalized, the regulation will be published in the Official Journal; a copy of the draft regulation can be found at the European Commission website.
http://ec.europa.eu/enterprise/tbt/tbt_repository/EEC381_EN_1_1.pdf