gempex WebSeminar Medical Devices: Product Approval in EU and USA – An Overview

Fundamental basics about approval in the target market is essential for medical device manufacturers. For example, for approval in the EU, manufacturers of Class I medical devices self-declare that their product meets the requirements of the Medical Device Regulation (MDR) and that a conformity assessment procedure has been performed in accordance with Article 52.

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Tuesday, November 23, 2021 | 10:00 - 11:00 a.m. | GERMAN
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Tuesday, November 30, 2021 | 10:00 - 11:00 a.m. | ENGLISH
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However, what about the risk classes above Class I of medical devices, combination products or in vitro diagnostics for a market authorization in Europe? Is it true that medical device manufacturers are also required in higher product classes to determine the conformity of their medical devices themselves and to pass a conformity assessment procedure for this purpose? What are the differences in the approval procedures and which annices are valid?

These are many questions when it comes to the approval of medical devices for the European market. But how does the approval procedure for medical devices for the U.S. market work? It is probably known that the FDA, a state authority, decides whether the product may be sold in the USA. The premarket notification according to 510(k) as probably the most important approval procedure is probably also known. But are differences made here, as in Europe, regarding the medical device class, or are there even requirements for the products that differ from those in the EU? How are combination products defined in the U.S., and what approval procedures do they face? Are IVDs treated similarly to medical devices?

The most basic questions of the entire topic will be answered in the upcoming gempex WebSeminar "Product Approval in EU and USA - An Overview". Due to the broad scope of the topic, the one-hour online event is an overview (including lesser-known approval pathways), but it is not intended to leave any questions unanswered. The aim of the WebSeminar is to provide an understandable overview of the special features and differences of product approval in Europe and the USA and to be able to assign one's own medical product to an approval procedure without any problems if the product classification is known. Lesser-known special paths for niche products will also be addressed.

Julia Tran, Consultant at gempex, and Phillip Stockmann, Senior Consultant at gempex, will lead through the WebSeminar, which is aimed at legal manufacturers for medical devices, contract manufacturers as well as distributors and importers and is offered in German and English language.



  • Basics of product approval in Europe and the USA
  • Overview and differences of the various approval channels (EU and USA)

Products and specific approval procedures

  • Definition of medical devices, combination products and in vitro diagnostics
  • Classification of medical devices, combination products and in-vitro diagnostics in the product approval process
  • Overview of the approval procedures that a product may be considered for



Julia Tran, M. Sc. in Biomedicine
Julia Tran is a consultant for Compliance in Quality and Regulatory Affairs. She has experience in organizational development, Lean Six Sigma, project management and quality assurance of various regulated pharmaceutical and medical device companies.

Philipp Stockmann, B. Sc. In Food Technology
Philipp Stockmann is a specialist in regulatory affairs. Before moving into consulting, he worked in regulatory affairs, quality control and quality management for various regulated industrial companies and medical device manufacturers.