The integration of notified body feedback into the regulatory pathway for combination products is a critical area. Understanding how these opinions influence product development and compliance would be insightful, particularly with the evolving EU MDR frameworks.
The workshop provides regulatory professionals with hands-on knowledge needed to obtain Notified Body Opinions (NBO) for integral drug-device combination products as specified in Article 117 of EU MDR 2017/745. The program focuses on important challenges such as regulatory classification difficulties, missing technical documentation elements and the interaction between National Competent Authorities (NCAs) and Notified Bodies. Participants will develop practical strategies for creating GSPR-compliant technical documentation and handling Notified Body questions through real-world case studies and interactive quizzes.
This workshop will teach participants how to choose the appropriate Notified Body and streamline submission processes while shortening review periods. This session delivers a detailed plan for working with Competent Authorities and Notified Bodies including BSI, TUV, DEKRA, etc. which allows participants to learn how to handle NBO submissions for medical devices like prefilled syringes and auto-injectors.
Registration Fees & Deadlines
Present – 11 May 2026: Early Bird Member $315 | Nonmember $370
12 May 2026 – 11 June 2026: Regular Member $370 | Nonmember $430
Learning Objectives
Upon the conclusion of the program, you will be able to:
- Explain how the Notified Body (NB) opinion process impacts the regulatory submission of combination products under MDR/IVDR.
- Apply compliance and precise regulatory strategy to get a successful notified body opinion report for their integral combination product in EU.
- Create a procedure for gathering information to compile the general safety and performance requirements for combination products.
Who Should Attend?
This workshop will benefit Regulatory Professionals in Pharma and Biotech
involved in developing integral drug-device combinations (e.g., prefilled syringes, auto-injectors) under Article 117 of EU MDR.
- Device Regulatory Affairs or CMC
- Design or Quality Assurance
- Device Engineering/Development
- Human Factors Engineering
- Clinical Operations
- Device Project Management
Audience Learning Level
Intermediate: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as knowledge checks, case studies, scenario building, and polling. A high level of participation is expected from each attendee.
Agenda
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Time
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Topic
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Duration
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9:00 am – 9:10 am
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Welcome and Course Overview
1. Introduction of Instructor
2. Learning Objectives and Agenda Overview
3. Interactive Poll 1: How familiar are you with Notified Body Opinions? (5 minutes)
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10 minutes
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9:10 am – 10:00 am
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EU MDR Overview and Role of Notified Bodies for Combination Products. Explore how the Notified Body (NB) opinion process impacts the regulatory submission of combination products under MDR/IVDR.
- Overview and Intro of EU MDR 2017/745 and Article 117 requirements for Combination Products. Define combination products and the distinction between drug-led and device-led combinations.
- EMA and Competent Authorities’ role in combination product approvals.
- Notified Bodies’ scope and responsibilities under Article 117 of MDR for drug-device combination products.
- GSPR requirements (Annex I) for integral drug-device combinations.
- Rule 14: Understanding scope and requirements.
- Key submission differences: EMA vs. Notified Bodies.
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50 Minutes
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10:00 am – 10:30 am
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NB Opinion Submission Process and Technical Documentation
1. Preparing for the Notified Body Opinion (Article 117)
2. Required documentation: Dossier and Design History File (DHF) essentials
3. Focus on Design Controls and Risk Management files
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30 minutes
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10:30 am – 10:40 am
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Break
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10 minutes
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10:40 am – 11:00 am
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4. GSPR Compliance Strategy: Aligning evidence to each requirement
5. EMA's expectations on bridging data for drug and device integration
6. Timeline and review process: From submission to NB opinion report
7. Interactive Poll 2: What’s your biggest challenge in GSPR compliance? (5 minutes
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20 minutes
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11:00 am – 11:50 am
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Challenges, Pitfalls, and Mitigation Strategies
1. Common pitfalls: Inadequate GSPR alignment, incomplete risk management, poor human factors evidence
2. Handling NB queries and non-conformities during technical review
3. Strategies for successful submissions, including using mock audits
4. Insights from TUV, BSI, and MHRA NB reviews on auto-injectors and prefilled syringes
5. Quiz 1 (5 minutes): 5 Questions on Submission Requirements
6. Poll (5 minutes)
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50 minutes
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11:50 am –12:00 pm
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Break
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10 minutes
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12:00 pm – 12:40 pm
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Case Studies and Best Practices
1. Case Study 1: Notified Body Opinion for a Prefilled Syringe (GSPR and Design File Pitfalls)
2. Case Study 2: Auto-injector Submission and Risk Management Findings
3. EMA and NB interaction examples
4. Interactive Poll 3: Which area do you find most critical for NB success? (5 minutes)
5. Quiz 2 (5 minutes): 5 Questions on GSPR and Risk Management Strategies
6. Group discussion on learning
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40 Minutes
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12:40 pm – 12:50 pm
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Wrap-up and Final Q&A (10 minutes)
1. Recap of Key Learnings
2. Process and Submission Requirements: Developing internal NB Opinion readiness protocols/templates
a) Detail the submission process, timelines, and dossier requirements.
b) Outline the NB opinion request and key content: GSPR, RMFs, and DHFs.
3. Resources for Further Study (RAPS, EU MDR Annex I, Article 117 Guidance, EMA/NB Q&A)
Closing Remarks and Contact Information
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10 Minutes
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12:50 pm – 1:00 pm
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Final Poll (5min) and Q&A
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10 Minutes
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Speakers
Elisabeta Burean
Notified Body Technical Representative, TUV SUD
Elizabeth is an expert for Combination Products at TÜV SÜD Product Service GmbH, one of the world’s largest EU Notified Body for the extensive range of medical devices covered by EU directives and regulations. TÜV SÜD Product Service GmbH is also a leading certification body for quality management systems, including systems applicable to medical device manufacturing.
With extensive experience in drug–device combination product development, medical device conformity assessment, and EU regulatory frameworks, Elizabeth is committed to supporting the evaluation of combination products in accordance with the safety and performance requirements of the European market.
Leonel Vanegas
Founder, Precision Regulatory Consulting LLC
Leonel focuses on helping clients develop and market healthcare products that aim to save and extend people's lives. With a background in quality and regulatory affairs, and a passion for innovation, he strives to make a meaningful impact in the healthcare industry. His mission is to enhance quality culture and deliver outstanding value through regulatory proficiency and client-focused consultancy.
Founder of Precision Regulatory Consulting (PRC) LLC, Leonel is an expert quality and regulatory consultant. Leonel’s expertise is in medical device and combination product regulations including ISO and EU MDR/IVDR. He support clients in product development, regulatory filings, commercial launch and audit readiness.
After almost three decades of industry experience, Leonel’s continues to drive initiatives for regulatory compliance and quality assurance, ensuring seamless collaboration with cross-functional teams to meet global standards.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.