;   Medical Translation Insight: Pigs DO fly! elabeling comes to Europe - ForeignExchange Translations

Pigs DO fly! elabeling comes to Europe

Pigs DO fly and elabeling does come to Europe (medical translation)
The adoption of e-labeling (i.e., the inclusion of digital instructions with medical devices) has been very slow in Europe. Because the European Commission's medical device directive was written over 20 years ago, and e-labelling was not even thinkable back then, Europe has lagged behind the U.S. and Canada.

Things are about to change in Europe. Commission Regulation (EU) No. 207/2012 on electronic instructions for use of medical devices was published in March of 2012 and will be applicable as of March 1, 2013. The regulation has a restricted scope, mainly focusing on implantable medical devices and their accessories and a number of specific requirements for the implementation of eIFUs. Among those are provisions for an eIFU website, a specific risk assessment, product labeling, and notified body surveillance.

While device manufacturers are eager to start e-labeling, questions have arisen in recent months on how to address the new requirements. In particular, product labeling and notified body surveillance have been identified as requiring further clarification.

On February 28, 2013, Joachim Wilke, Medtronic's Director of Regulatory Affairs & Policy, will answer some of these questions. In his audio conference eLabeling in Europe -- How to Start and What to Expect from Notified Bodies he will provide an overview of the regulation, focusing on the joint industry eIFU labeling guidance and the as-yet-unpublished notified body recommendation paper (to harmonize their approach towards manufacturers when reviewing design dossiers, technical files and auditing eIFU relevant processes of the quality management system).

As Eucomed's chair of the Alternative Labelling Taskforce and as a member of its Regulatory Affairs Council, Joachim brings unparalleled insights to the topic. Any medical device company thinking about making the switch to e-labeling need to attend this conference. Similarly, medical translation professionals should get prepared for the big changes coming to our business. Register here.


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