Clinical Investigations or studies are easily the most expensive and time–consuming endeavors undertaken by a medical device manufacturer on the path to CE Marking. Errors in communication, planning, conduct, evaluation, or reporting of clinical studies are currently the main causes for serious delay of market access in Europe. In this whitepaper, you will learn:
- When is a study required
- Possible study structures: open label, non-inferiority and RCT
- The quality of the data and the use of a CRO
- Acceptability of foreign data
- The link with the Risk Management File
- An overview of changes under Europe's new Medical Devices Regulation (MDR 2017/745)
Note: This paper focuses on the actual situation in Europe only.
About the Author:
Jaap Laufer, MD, PharmD is Vice President of Regulatory and Clinical Affairs at Emergo.