Final publication of the European Commission’s regulations covering electronic instructions for use (e-IFUs) will occur March 30, 2012.
According to BSI, medical device manufacturers will have one year to ensure their e-labeling processes are compliant with the new regulation. As such, the law officially takes effect March 1, 2013.
The following products fall under the new regulation:
- Active implantable medical devices as well as accessories compliant with Directive AIMD and Directive 90/385/EEC intended for use solely for implantation or programming of defined active implantable devices
- Implantable devices and their accessories compliant with Directive 93/42/EEC intended for use solely for implantation of defined implantable devices
- Fixed, installed devices compliant with Directive 93/42/EEC
- Devices and accessories compliant with 90/385/EEC and 93/42/EEC
- Stand-alone medical software compliant with Directive 93/42/EEC
Compliance with the e-IFU regulation will also require risk assessment surveys to assess Internet availability as well as hardware and software skills necessary to meet the new requirements.
Although complying with the e-IFU regulation will not be an insignificant issue for many manufacturers, at least the new rules will be implemented consistently throughout all EU member states. Because the new rules will be implemented as regulations rather than directives, member states will not have to transpose them into their own individual legislative systems. In other words, manufacturers will have to comply with a single, uniform regulation rather than 27 versions of the same rule.