Get the very latest on European medical device labeling, from a leading expert!

This audio conference discusses the background and status of the upcoming legislation on elabeling for medical devices in the European Union. Based on the most recent available EU Commission draft, it covers the scope of medical devices being considered for elabeling, as well as general requirements and envisaged provisions for risk assessment, user information and Notified Body surveillance. Our speaker, who chairs Eucomed's Alternative Labeling Task Force, also reviews a number of topics still under discussion, and provides information about the political process and expected time scenario – as well as factors which could lead to potential delays. The presentation also raises some practical considerations on the implementation of elabeling for medical devices.

This audio conference covers:

• Status of EU elabeling legislation
• Expected scope
• Expected requirements
• Implementation issues

About the speaker:

Joachim Wilke is Director of Regulatory Affairs & Policy in Europe with Medtronic. He holds a PhD in Biology from the University of Constance and a Master of Science in Pharmacological Medicine from University Essen-Duisburg.

Joachim started his professional career in 1986 at Dornier Medizintechnik in Munich working in R&D on medical applications and biological side effects of shock waves. Later he became responsible for the conduct of clinical investigations with medical devices. Still employed by Dornier he then specialized in Regulatory Affairs (RA) working in the US and then again in Germany with worldwide RA responsibility.

In 1993 Joachim joined Medtronic as Manager of Technical Scientific Services in Germany. In this function his responsibilities included Regulatory, Quality, Clinical, Technical Service and Training & Education. In 2003 he became responsible for Regulatory Affairs, Quality and Compliance of Medtronic Germany, Austria and Switzerland. In 2009 Joachim took over a RA function for Medtronic Europe being responsible to monitor new developments in European medical device regulations including Environmental legislations and provide internal company guidance on their implementation.

He is a member of the Regulatory Affairs Council of Eucomed and Chair of Eucomed's Alternative Labeling Task Force.

Who should attend?

• Regulatory Affairs
• Packaging & Labeling Engineers
• Risk Management