Online Training
Drug Device Combinations
Overview of product categories & regulatory requirements (incl. Article 117)
![](https://www.akrateam.com/wp-content/uploads/2024/05/shutterstock_1980760232-DDCs-combinations-Devices-5000x2617-1-1024x536.jpg)
Available Dates & Times
● 05. Sep 2024:     09:00-13:00 h CET
Description
Drug-Device-Combinations (DDCs) represent a heterogenous group of products, which are a combination of medical devices on one hand and pharmaceutical products on the other. This product group has evolved significantly over the past years as it bears a high potential of clinical benefits for treatment off various types of diseases.
The product spectrum ranges from simple prefilled syringes (filled with a drug component), auto injection devices to complex delivery on demand devices which are implanted (e.g. insulin pumps). Other devices represent a combination of a traditional medical device (e.g. a stent) coated with a pharmaceutical to improve the clinical outcome of the treatment (e.g. drug eluting stent). Depending on the principle mode of action, either the medical device regulation (Regulation 2017/745) or medical products directive (Directive 2001/83/EC) is the primary applicable legislation.
This has significant impact on the legislative processes to be applied. In addition, article 117 of the EU MDR specifically bears new obligations for pharmaceutical manufacturers.
The seminar will provide a structured step by step approach, how to differentiate between the different types of DDCs and the respective applicable legislation.
Net price
€ 330
- Access to online training
- Presentation slides as handout
- Participation certificates
Overview of covered topics
- Definition / Wording / Nomenclature
- Types and variants of Devices, combining MDs & MPs
- Decision making process & stakeholders involved
- Overview & characteristics of different combinations: Medical Devices + separate Medicinal Products > Non-integral devices, but interrelated MDs and MPs / DDCs - Integral > MD has Principal Mode of Action / DDCs - Integral > MP has Primary Mode of Action
- Sources of information
Purpose of the training
The following targets are aimed at:
- Gaining an overview about various types of Drug-Device-Combination Products
- Understanding the applicable legislation and stakeholders involved
- Providing an overview about the processes
- Understanding the differences between the various product types regarding legislation
Who should attend
- Pharmaceutical Manufacturers
- Clinical Affairs Manager
- Regulatory Affairs Manager
- Clinical Affairs Experts
- Subject Matter Experts
Basic knowledge required
- EU-MDR Basic knowledge
- Basics in medicinal products
Presenting experts
![](https://www.akrateam.com/wp-content/uploads/2023/06/Markus.png)
Prof. Dr. Markus Balkenhol
Team Leader - Senior Clinical Consultant
AKRA TEAM GmbH
![](https://www.akrateam.com/wp-content/uploads/2023/06/Anna.png)
Dr. Anna Spehl
Senior Consultant
AKRA TEAM GmbH
![](https://www.akrateam.com/wp-content/uploads/2023/06/Norchene.png)
Norchéne BenMadhi
Consultant
AKRA TEAM GmbH
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