About
Combination Products under the EU Medical Devices Regulation (MDR)
The implementation of the EU Medical Devices Regulation (MDR) 2017/745 has brought significant changes to the regulatory landscape, impacting both the pre-clinical and clinical components of medical device dossiers, the market approval process, and the roles of notified bodies in conformity assessment.
As research and innovation progress, the range of device-drug and drug-device combination products is expanding. The MDR introduces a new approach for demonstrating compliance for integral device-drug combinations via Article 117.
This training program provides participants with:
- An overview of the requirements for combination products under the MDR
- Guidance through the regulatory conformity pathways for combination products
- A clear understanding of the regulatory requirements for devices containing medicinal substances and devices provided in combination with medicinal products (DDCP)
- Practical insight into achieving compliance, including requirements for regulatory documentation and CE marking
Programme
MODULE 1
Understanding Combination Products
- Definitions in device and drug regulations
- Classification of combination products
- Exploring differences and similarities in regulatory approaches
- Case studies and quiz
Medical Devices Regulation 2017/745
- Introduction to MDR
- Transition for industry and notified bodies
- Key changes for the industry
- Latest developments and future steps
MODULE 2
Device Conformity Assessment
- Overview of conformity assessment
- Process for CE marking, preparation of the technical dossier, and recent changes
- Demonstrating compliance with safety and performance requirements (GSPR)
- Case study: Syringe
Device-Drug Combinations
- Guidance and conformity assessment processes
- Role of the European Medicines Agency (EMA)
- Technical documentation related to the drug component
- Updates related to medicinal substances
Drug-Device Combinations
- Impact of MDR Article 117 and related EMA guidance
- Technical documentation and the Notified Body Opinion (NBO)
- Incorporating device data in the drug Common Technical Document (CTD)
- Recent changes
- Case studies and Q&A session
This course is designed for professionals from both pharmaceutical and medical device companies who work in Quality Assurance, Regulatory Affairs, Clinical Operations, Medical Writing, Research & Development, or hold executive roles such as CEO or CTO.
It is also beneficial for those in the industry, pharma and biotech companies, contract research organizations (CROs), research centers, and university faculties specializing in applied sciences and biotechnology involved in the development, manufacturing, and sales of DDCPs.
Participant experience
Familiarity with the Medical Devices Regulation (MDR) 2017/745 is an advantage, but newcomers are also welcome to participate.
The training will use a combination of knowledge transfer, interactive sessions, case studies, and group discussions to facilitate learning and application.
Lecturers
Arkan Zwick
Mr. Arkan Zwick is the Corporate Regulatory Affairs Director at a private global pharmaceutical and surgical company with products in ophthalmology, orthopedics, and aesthetic dermatology. With over eighteen years of regulatory experience, his responsibilities span advocacy for drug, medical device, combination product, and cosmetic compliance, as well as providing in-house legal support for contract management, mergers and acquisitions, and intellectual property matters. Mr. Zwick ensures regulatory compliance in the EU, collaborates with various notified bodies, and manages global market authorizations in the Americas and Asia-Pacific. He holds a master’s degree in law from the University of Vienna and a PhD in European Law, teaches at the University of Applied Sciences in Vienna, and is a frequent speaker at life cycle conferences and trainings. He is fluent in English, German, and French.
Online Training – 2 modules
MODULE 1 | 07 October 2026 from 2:30 pm to 5:30 pm CEST
MODULE 2 | 08 October 2026 from 2:30 pm to 5:30 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 690,00* (until 16 September 2026)
Ordinary: € 885,00*
Freelance – Individual – Academy – Public Administration: € 495,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Register
Printable Version
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.