Are you developing a in vitro diagnostic device for the health sector? Are you unsure if you need to adhere to the In Vitro Diagnostic Medical Device Regulations? Or what the risk classification of your device is according to the In Vitro Diagnostic Medical Device Regulations? Or which requirements your device need to conform to? Then this workshop is for you.

Detailed Description

The objective of this workshop is to learn the first key aspects of the In Vitro Diagnostic medical device regulations: to determine when a product is a in vitro medical device, what the risk classification of the device is and what the next steps are.  

Who should attend? 

People who are working in the area of In vitro diagnostic medical devices, including: academic 
researchers, clinicians, science students, innovators, start up’s, SME’s, research council, research 
services and tech transfer support. 

What will I learn? 

By the end of the workshop delegates will be able to: 
• Identify if a device is an In vitro diagnostic medical device. 
• Classify a device according to the In Vitro Diagnostic Medical Device Regulation (EU) risk 
levels. 
• Find the requirements that In Vitro Diagnostic medical devices need to conform too. 
• Hands on experience in using the regulatory tool: RegMetrics.