Transitioning to the New EU MDR and IVDR: A Workshop on Real World Implementation Experiences


This is a can’t miss opportunity to learn from experienced regulatory affairs professionals who are closely engaged with the practical application of the new EU regulatory requirements who will share valuable insights and unique perspectives on how to address the challenges of the new regulations. Sessions will include keynote speakers from the European Commission; updates on the Competent Authority Medical Devices (CAMD) roadmap relevant to all device/IVD manufacturers; and both an MDR and an IVDR track that will dig deeper into new clinical expectations, general safety and performance, technical documentation, labeling and post market requirements.

Join our next MDR workshop in Brussels for expert interpretation of new expectations. Be prepared to develop your own transition plans to navigate market access (CE Marking) expectations for both new and legacy devices being placed in Europe.




Wednesday, 16 May 2018 (09:00 - 16:30) – Thursday, 17 May 2018 (09:00 - 16:30) 2018
Thon Hotel
Rue de la Loi 75
Brussels, Belgium

Until 16 April 2018:
Member Price: $750
List Price: $850

17 April 2018 to 9 May 2018: 
Member Price: $850
List Price: $950




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Virtual Program

Understand the New EU Medical Device/IVD Regulations Webcast Understand the New EU Medical Device/IVD Regulations

View it on demand

Part 1 | Part 2 | Part 3 | Part 4

This four-week virtual program draws together industry experts and leading Notified Bodies who have been closely following the evolution of the proposed regulations, anticipating the final texts, developing positions on what will be required by the regulations, and understanding the impact on manufacturers, devices and systems both new and legacy.

Uniquely, each week provides different perspectives/opinions from different Notified Bodies and experts on the key significant changes that will impact all medical devices and in vitro diagnostics being placed into Europe under the new European Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). This program will also consider the impact on legacy devices cleared, CE marked, and under the existing EU Medical Device Directive (MDD) and In Vitro Diagnostics Directive (IVDD).

From the convenience of your own viewing location, this cost-effective resource is one you can watch live with your colleagues. Recordings of the sessions will also be available with your registration.

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