Since the publication of MEDDEV 2.7/1 rev4 and the Medical Devices Regulation (MDR), clinical data is under heavy scrutiny by Notified Bodies and Competent Authorities in Europe. That scrutiny – and the burdens placed on medical device manufacturers – leaves some companies at risk of losing their CE certifications following routine Notified Body re-certification audits. In this free webinar, we will examine the clinical data and literature review requirements found in MEDDEV 2.7/1 revision 4 as well as the changing regulatory environment as it relates to these requirements.
WHAT YOU WILL LEARN:
• Clinical data requirements in the MDR and MEDDEV 2.7/1 revision 4
• How to determine whether a device is equivalent to your own
• Requirements on searching for literature and whether your clinical literature reviews will be accepted by your Notified Body
• Collating and appraising the data
• Documenting your evaluation
• Updating your CERs and the importance of PMS data
• Looking to the near future - clinical data requirements in the MDR
ABOUT THE PRESENTER:
Jane Arnold‐Round has 25 years of experience in the medical device industry. She has held technical and regulatory positions with Medtronic, Sulzer Vascutek, AstraZeneca and BSI, the UK Notified Body. During her tenure with BSI, she gained extensive experience in reviewing technical files and design dossiers (including CERs) and was responsible for classification, borderline issues for medical devices utilizing animal tissue and numerous drug‐device combination design dossier reviews. Jane has been a Senior Consultant on our UK team since 2004, assisting hundreds of device clients with CE, risk analysis, biocompatibility and, of course, endless issues related to clinical data.
This webinar was recorded on February 21, 2018.