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Mastering the Notified Body Opinion Process: EU Compliance for Drug–Device Combinations
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Mastering the Notified Body Opinion Process: EU Compliance for Drug–Device Combinations

10 March 2026 | Short Online Course

Original price was: $492.Current price is: $394.

1-Day Live Online training | Confidently prepare, submit, and navigate the Notified Body Opinion process for EU drug–device combination products

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Enrol before 13 February to save 20% (March Course)

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

The Notified Body Opinion (NBOp) is a critical requirement under the EU Medical Device Regulation (MDR) for medicinal products incorporating a medical device component. It ensures that the device part of a combination product complies with relevant safety and performance requirements.

 

This course provides a step-by-step guide to the NBOp process, including regulatory expectations, dossier preparation, interactions with Notified Bodies, and common pitfalls. Through case examples and practical advice, participants will gain confidence in managing NBOp procedures effectively to support successful submissions.

 

Learn more about how we deliver live online training.

Download the Agenda

 

You can view the agenda by scrolling down on this page. If you would like to receive a PDF version with all the course information, please complete the form below.

 

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Key Learning Objectives

 

  • Understand the legal basis and scope of the NBOp under the EU MDR
  • Identify when an NBOp is required and which products fall under its scope
  • Prepare the technical documentation required for NBOp review
  • Understand the roles of the EMA, National Competent Authorities, and Notified Bodies
  • Navigate interactions with Notified Bodies and manage timelines effectively
  • Anticipate common challenges and avoid pitfalls in the NBOp process

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer through interactive and engaging sessions
  • Unlimited access to session recordings for 2 weeks after the course (live format)
  • One month of unlimited access to recordings and slides (on-demand format only)
  • Validated certificate of attendance, available to download or share on LinkedIn

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

10 March 2026

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

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered online.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)

 

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.

 

This course is designed for professionals working in:

  • Regulatory Affairs (Medicinal & Device)
  • CMC and Pharmaceutical Development
  • Combination Product Development Teams
  • Quality Assurance and Compliance
  • Project Managers involved in EU submissions

On-Demand Access

Can’t wait for the next course date?

Get instant access to the training materials by selecting ‘On-Demand’ from the drop-down menu above. Start learning at your convenience. You’ll also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.

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Mastering the Notified Body Opinion Process: EU Compliance for Drug–Device Combinations

10 March 2026 | Short Online Course

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