Upstate Medical University

RAPS Presents: Combination Products for Medical Devices (Rule 14) Online Workshop

In the EU the demarcation between medical devices and medicinal products and the appropriate regulatory route to approval is becoming ever more important and complex with the convergence of emerging novel technologies that challenges the borderline space.

This online workshop outlines the European requirements for combination products, helps you understand the borderline area and allows you to define the regulatory route for your product.

This program also details:

  • The medical device CE certification conformity assessment process and Notified Body expectations for devices containing ancillary medicinal substance
  • Devices containing ancillary human blood derivative
  • The Competent Authority Medicinal Consultation process, options available, timelines and documentation expectations
  • Post-CE certification expectations and change management.

Registration Fees & Deadlines

27 July 2023 - 30 November 2023: Member $580 | Nonmember $680

To Register: Combination Products for Medical Devices (Rule 14)| RAPS

Learning Objectives

  • Gain an appreciation of the borderline area between medical device and medicinal products in the EU
  • Understand the importance of the correct regulatory classification and differences in regulatory requirements for medical devices and medicinal products
  • Understand the CE Certification process for a medical device with ancillary medicinal substance / human blood derivative
  • Appreciate the roles and responsibilities for all stakeholders involved in the process
  • Understand the documentation requirements for your device

Audience Learning Level 

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Who Should Attend?

This course is recommended for Development Scientists or Regulatory personnel in the medical device industry, who are interested in medical devices incorporating medicinal or human blood derivative ingredients


Day 1

  • Introductions
  • Medical device & medicinal product borderline area
  • Classification
  • Key definitions
  • Differences in the regulatory approval process medical device Vs medicinal Product
  • Conformity assessment process

Day 2

  • Recap of Day 1
  • Key stakeholders – Roles and responsibilities
  • Documentation expectations for the CA / EMA consultation
  • Common gaps in development data
  • Common CA questions
  • Useful guidance
  • Review and summary


Theresa Jeary
Principal Technical Specialist & Trainer, Medicinal & Biologics, Meddev Solutions

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.orgCancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.


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 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.


Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email