We need to translate our IFUs, pharmaceutical documents or package inserts

My team and I will work closely with you to understand your particular requirements to ensure that the final package and IFU labeling fully complies with local medical regulations outside of the USA. If you want to sell your products overseas you need to know the requirements of the country you will be selling. Let us guide you through the entire process of translating your IFUs and packages in such a way that they fully abide by all medical regulations in your target countries.
Commission Regulation EU 207/2012 on EIFUs for medical devices is applicable in all EU member States without the need for any member state transpositions. The regulation defines EIFUs as instructions available from a Web site, supplied in portable electronic media (e.g., CD, DVD, USB drives), or displayed in electronic form on the product screen. In the latter two cases, manufacturers are also required to provide instructions on a Web site. The regulation allows EIFUs for the following types of devices:

  • Active implantable medical devices and their accessories, covered by Directive 90/385/EEC (AIMDD) and intended to be used exclusively for the implantation or programming of a defined active implantable medical device.Implantable medical devices and their accessories, covered by Directive 93/42/EEC (MDD) and intended to be used exclusively for the implantation of a defined implantable medical device.Fixed installed medical devices covered by Directive 93/42/EEC.
  • Medical devices and their accessories, covered by Directives 90/385/EEC and 93/42/EEC and fitted with a built-in system visually displaying the instructions for use.
  • Stand-alone software covered by Directive 93/42/EEC.

EIFUs for such devices can be provided only when they are intended for exclusive use by professionals (e.g, in a healthcare setting) and use by others is not reasonably foreseeable. If the device design requires that a part of the instructions is intended to be provided to the patient, the regulation requires that part to be in paper form.

PDF version of entire law

 

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E-mail: jorge.berriatua@icbmed.com