Drug Device Combinations
Overview of product categories & regulatory requirements (incl. Article 117)
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.
Overview of covered topics
Purpose of the training
The following targets are aimed at:
Who should attend
Basic knowledge required
Dr. Anna Spehl
AKRA TEAM GmbH
AKRA TEAM GmbH
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