Compliance with the Medical Device Regulation (EU) 2017/745 (MDR) presents many new challenges to Medical Device manufacturers. Our in-depth MDR training is designed to help you and your team prepare for these challenges and transition smoothly to the MDR.
This course focuses on what is required to bring your Medical Device to market under Medical Device Regulation (EU) 2017/745 (MDR).
Learn how to interpret and navigate the new regulations, determine device classification and understand device conformity assessment routes. The course will address the enhanced requirements under the Regulation; General Safety and Performance Requirements (GSPRs), Clinical Evidence, Post Market Surveillance including Periodic Safety Update Report and Vigilance etc. The course will also look at the role of Competent Authorities and Notified Bodies.
Also covered during the course are the requirements to keep your device compliant under the existing Medical Device Directive whilst your CE Certificate remains valid.
The course will feature interactive workshops, include an in-depth look at ISO 13485 and provide the opportunity for one to one discussion with the Course Tutor at break-out sessions. Delegates complete a gap analysis exercise, allowing you to review your current products and assess compliance against the new legislation.
Classroom courses - please note, the advertised venue may need to be changed, if the required number of delegates is not met. In this situation, the course will be converted to an Online Virtual course and all delegates notified accordingly. The decision regarding the venue will be made at least 4 weeks before the course is due to run.