European Notified Bodies are under intense scrutiny by Competent Authorities, and that oversight has filtered down to their clients. A few years ago, there were more than 80 Notified Bodies authorized to audit and certify medical devices. Today there are 57 and that number is expected to drop further in the next few years. Also, some Notified Bodies are narrowing their scope. With looming deadlines for ISO 13485:2016 in 2018 and a strict new MDR coming into effect in 2020, some Notified Bodies will inevitably leave their clients flat footed with CE and ISO certifications at risk. In this recorded webinar we tell you how to deal with the issue of transitioning to another Notified Body and/or how to evaluate your options in establishing a new relationship.
WHAT IS COVERED IN THIS RECORDED WEBINAR:
- Factors driving the reduction of Notified Bodies and their scope
- How to make sure you won't be blindsided by your NB
- Factors to consider in choosing a new Notified Body
- Establishing evaluation criterai and creating a transition checklist
- How to avoid paying astronomical fees for expedited NB reviews
- Planning a transition strategy
About the Speaker:
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.
Recorded in February 2017
How to Select and Change a Notified Body in Europe
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. Download now.