Compliance with the forthcoming 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.
The course is intended for individuals that work for a Medical Device manufacturer or CMO who's responsibilities require them to have an understanding of Medical Device Regulation (EU) 2017/745 and the differences/issues from the current MDD. In particular Quality Management, Quality Assurance, Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Authorized Representatives, Economic Operators, including importers and distributors.
At the end the course, you will be able to:
- Understand the key differences between MDD and the new MDR
- Understand how to transition from MDD to MDR
- Understand how to navigate the 2017/745/EU standard
- Classifying medical devices under the European MDR
- Safety and performance requirements
- Identify the implementation steps required to meet MDR