How to Select and Change a Notified Body in Europe

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Selecting the right Notified Body for your company might be one of the most important steps to selling your medical devices in Europe. Learn about items to consider when choosing a Notified Body which will help (not hinder) your company's needs and sales goals.

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Selecting a Notified Body (NB) is an important (and required) step for obtaining CE Marking and registering your medical device for sale in the European Union. Your Notified Body audits your quality management system and reviews your Technical File to ensure it complies with the appropriate EU Directive.

There are many accredited Notified Bodies in Europe - but some may be better suited to partner with your company than others. This article discusses key points of the Notified Body search, including how to find a new Notified Body partner. You will learn:
  • What is the difference between a Notified Body and a Registrar?
  • What should we consider during our search?
  • What should we consider when reviewing proposals from Notified Bodies?
  • What are reasons we might need to switch Notified Bodies?
  • What are the logistics of switching Notified Bodies?

We answer all these questions and more in this 5-page white paper.

About the Author

Jaap Laufer, MD, PharmD is Vice President of Regulatory & Clinical Affairs at Emergo. Dr. Laufer has over 30 years of experience in the medical device and pharmaceuticals industries. He previously held executive and senior regulatory positions at Pfizer, Abbott Laboratories, LipoMatrix, and others. His areas of expertise include a vast array of mostly implant and higher classed products, ISO and FDA QSR audits, and clinical study approvals and compliance. He holds a PharmD in Pharmacy from the University of Groningen and is an MD from the Medical School of the University of Nijmegen, both in The Netherlands. Dr. Laufer is a member of the Medical Devices Expert Group to the EU Commission and teaches at the University of Southern California in Los Angeles, USA.