EU publish much awaited draft regulation for e-labelling of medical devices

The European Commission has finally issued it’s much awaited draft regulation on e-labelling, the final version of which is expected to be adopted by 14 December and come into force during 2012.

The proposed regulation sets out conditions under which instructions for use in paper format may be replaced by electronic versions with respect to medical devices that are intended for exclusive use by professionals users and for which use by other persons is not reasonably foreseen.

While acknowledging the benefits of e-labelling, the commission states that the possibility of providing instructions for use in electronic form instead of paper should be limited to certain medical devices and accessories intended to be used in specific conditions.

For reasons of safety and efficiency the draft regulation indicates that medical device users should always have the option of obtaining the instructions for use in paper form on request. The regulation also includes several other procedural safe guards. For example, it requires manufacturers to carry out a documented risk assessment to ensure the appropriateness of providing electronic instructions. This risk assessment should, among other things, demonstrate that providing electronic instructions maintains or improves the level of safety achieved by providing the instructions for use in paper form. The risk assessment will need to be updated in view of experience gained in the post market phase.

The proposed regulation states that electronic instructions for use should be available through a website to ensure unconditional access and to facilitate the communication of updates and product alerts. Regardless of the language related legal obligations imposed by EU member states, the regulations state that manufacturer should indicate on their website in which EU languages the electronic instructions for use are available.

Except for class I medical devices, the commission believes that the fulfilment of obligations laid out in the regulation should be reviewed by a notified body. The draft regulation lists the devices for which electronic instructions for use can be provided.

When finalised, the regulation will be published in the Official Journal and is expected to come into force one year after the publication date.

For a copy of the draft regulation can be found at the European Commission website. Contact KD&A for assistance to establish e-labelling for your medical device.