On 8 June 2011, the European Commission Directorate General for Enterprise & Industry sent the draft regulation document on electronic instructions for use of medical devices in the framework of the Technical Barriers to Trade agreement (TBT) to the World Trade Organization (WTO).
Technical regulations and product standards may vary from country to country. Having many different regulations and standards makes life difficult for producers and exporters.
The Agreement on Technical Barriers to Trade tries to ensure that regulations, standards, testing and certification procedures do not create unnecessary obstacles.
The draft regulation on electronic instructions for use of medical devices 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 of 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; additionally a specific risk assessment by the manufacturer and information on how to access to the instructions for use is required. The draft Regulation also implements a few basic safety requirements for:
- Instructions for use in electronicform which are provided in addition to complete instructions for use in paper form
- Websites containing such instructions for use
For some medical devices the provision of instructions for use in electronic form instead of in paper form can be beneficial for professional users. It can reduce the environmental burden and improve the competitiveness of the medical devices industry by reducing costs, while maintaining or improving the level of safety.
Stakeholders can send their comments by 8 August 2011.
The Eucomed Alternative Labeling Task Force will meet on 1 July 2011 to analyse this latest version of the proposal, which was previously extensively discussed with the European Commission during its initial development.
For more information on the Eucomed Alternative Labeling Task Force or if you have any questions, please contact Dario Pirovano (Dario.pirovano@eucomed.org).
