Detailed Description

Are you developing a device or digital solution for the health sector and are contemplating deployment within the EU? Are you unsure if you need to adhere to the EU Medical Device Regulations (MDR) or how to risk classify your medical device? Are you aware of the requirements a medical device needs to conform to in order to achieve MDR certification?  

The objective of this HRC workshop is to learn the first key aspects of the EU Medical Device Regulations: to determine when a product is a medical device, what the risk classification of the device is and what the next steps are.  

Who should attend? 

People with an interest in the development of medical devices / digital health solutions, including: academic researchers, clinicians, students, innovators, start-ups, SMEs, research councils, research services and tech transfer organisations. 

What will I learn? 

By the end of the workshop attendees will be able to: 

·       Identify if a device / digital health solution is classified as a medical device under the EU MDR. 

·       Classify a medical device according to the EU MDR risk classification system. 

·       Find the requirements that medical devices need to conform too. 

·       Gain practical experience of using the regulatory tool: RegMetrics.