U kunt hier meer informatie vinden. Hieronder leest u de uitnodiging van EDMA:

EDMA is pleased to invite you to a one and a half day Workshop on the Implementation of the IVD Regulation on 13 and 14 October 2016. I enclose a preliminary draft agenda and a registration form. Also attached please find a list of hotels in the area (please note that you may take advantage of the MedTech Europe rates in the enclosed list).

On 25 May 2016, the Council and European Parliament announced that they had reached a political agreement. The result of this agreement is a ‘consolidated text’ of the IVD Regulation which has been made available and is expected to be essentially the same as the IVD Regulation text which will be officially published early 2017. This means that we can plan now for implementation of the IVD Regulation based on the consolidated text which is already available today.

This workshop will:

• Introduce the main impact changes from the IVD Directive to the IVD Regulation and highlight the issues
• Explain the transition from the directive to the regulation and transitional measures (what happens when and where there are questions)
• Look at how countries and companies are already approaching implementation
• Provide a participants’ break-out session to discuss our priority focus areas for implementation of the regulation in more depth
• Have a roundtable session to raise concerns or questions for industry
• … and more!

How to register

This workshop is free of charge and open to:

• EDMA Corporate Associate Members (CAMs)
• IVD industry members (manufacturers) and staff of the National Association Members (NAMs) affiliated to EDMA
• EDMA Associate Members

 In order to register, please complete the attached registration form and return it to Kacper Olejniczak (k.Olejniczak@medtecheurope.org) by Friday 30 September 2016.

EDMA will coordinate a dinner for interested participants on 13 October – more details will follow soon.