New EU Electronic Labeling Rules for Medical Devices Coming in March 2013
The EU Commission Regulation on electronic labeling will come into effect on 1 March, 2013.
This regulation outlines how Instructions for Use may be provided in electronic format to professional users for certain medical devices under the Medical Device Directive and Active Implantable Medical Device Directive. Under Community legislation, electronic labelling of medical devices is limited to manufacturers of eligible devices under certain conditions. For instance, the manufacturer must perform a specific risk assessment that considers the possible unavailability of the Internet and other scenarios.
According to guidance recently published by the UK Competent Authority MHRA, the review by a Notified Body of devices with electronic labelling will duly consider the risk classification and complexity of the product.