Course Outline

Course Information

• The course begins at the time stated at the top of the page
• The course is broken up into modules outlined below
• There will be breaks between modules

10 March 2026

1-Day Live Online Training
Register at the top of the page.

Session 1

120 mins | 10:00 AM UK

Introduction to the NBOp

• Legal framework under MDR Article 117
• When is an NBOp required? (examples of drug–device combinations)
• Key stakeholders: EMA, NCAs, and Notified Bodies
• Scope and limits of the NBOp

Documentation & Submission Requirements

• Technical documentation required for device assessment
• General Safety and Performance Requirements (GSPRs) relevant to NBOp
• Preparing the device dossier and integrating with the MAA (Module 3 CTD)
• Role of standards and guidance documents

Session 2

120 mins | 10:00 AM UK

Working with Notified Bodies

• Selecting a Notified Body and managing contracts
• Process flow and expected timelines
• How NBOp fits into EMA/NCA review procedures
• Communication and best practices for smooth interactions

Challenges, Pitfalls, and Case Studies

• Common deficiencies identified by Notified Bodies
• Strategies to address data gaps and avoid delays
• Case examples of successful NBOp submissions
• Future developments and regulatory outlook

Wrap-Up & Q&A

Richard Young has over 20 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.

Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.

Richard has worked on many software related projects for clients helping them achieve regulatory compliance in the EU. In addition, he has delivered both online and classroom training courses on medical device software. He can provide multiple examples and case studies during training, drawing on his extensive industry experience.