Seminar "Regulatory Requirements for Distributors and Importers"

The seminar covers the following topics:

• Fundamentals of the Medical Device Regulation 2017/745 (MDR):
  • Regulatory basis for placing medical devices on the market or making them available in the EU
• Specific duties and responsibilities:
  • For importers: Familiarization with the obligations under Article 13 of the MDR, e.g., reviewing documents and product characteristics, registrations in the EUDAMED database, stopping the placing on the market in case of non-conformities
  • For distributors: Understanding the obligations under Article 14 of the MDR, including checking the CE marking, declaration of conformity, and the correct language of the instructions for use, as well as reporting discrepancies to the competent authorities
• Understanding roles:
  • Clarification of roles in specific business constellations and discussion of cases in which an importer or distributor becomes a manufacturer themselves in accordance with Article 16 of the MDR. This is critical for understanding one's own responsibilities and avoiding liability risks.
• Practical significance of the requirements:
  • Participants discuss and resolve issues of understanding relating to regulatory requirements to develop appropriate solutions for their specific situation. Interactive examples help to translate theory into practical knowledge. 

After completing the seminar, you will be able to:

• clearly define and implement your duties and responsibilities as an importer or distributor in accordance with the Medical Device Regulation 2017/745 (MDR).
• identify risks in your business operations and develop effective strategies to avoid liability risks and regulatory sanctions.
• understand the requirements for the correct placing on the market and offering of medical devices in the EU and act in compliance.
• determine the specific roles and responsibilities in the context of the Medical Device Law and react to changes on your own, for example, when a distributor or importer becomes a manufacturer in accordance with Article 16 of the MDR.
• correctly apply the regulatory requirements in daily practice. 

You will be familiar with:

• the most important regulatory requirements for medical devices in the EU, which will help you to fully and correctly comply with your tasks as a distributor or importer in accordance with Articles 13 and 14 of the MDR.
• the necessary steps for registration in the EUDAMED database and for ensuring the conformity of medical devices, including CE marking and the declaration of conformity.
• the practical significance of these requirements for your specific business situation and how you can optimize your processes based on this. 

This seminar is designed for:

• Importers of medical devices: Individuals or companies that place medical devices from non-EU countries on the European market for the first time. They must understand the specific regulatory requirements and their correct implementation to comply with EU regulations.
• Distributors of medical devices: Individuals or companies that trade or distribute medical devices within the EU. These include wholesalers, retailers, and online sellers, who must be aware of their obligations and the necessary control procedures for selling medical devices within the EU.
• Top management and decision-makers in companies that import or trade medical devices: Executives who make strategic decisions and must ensure that their company complies with regulatory requirements.
• Quality management and compliance officers: Professionals who are responsible for regulatory compliance in their organization and need specific knowledge of the MDR.
• Regulatory affairs professionals: Employees who deal specifically with regulatory issues and the conformity of medical devices.
• Startups and new market entrants in the medical device field: New companies or entrepreneurs seeking to enter the European market for medical devices require a thorough understanding of the relevant legislation. 

Participants can easily follow this seminar even without any special prior knowledge. A basic understan­ding of medical devices and their use, including general knowledge of market requirements and standards, is helpful.

After registering, you will receive a confirmation email containing the meeting link, the time, and information about the participants.  

An invoice will be sent to you within the next 48 hours, with a payment term of 14 days. If this payment term is not feasible for your company, please send a short e-mail to [email protected] to find a solution.  

Three days before our online seminars and workshops, you will receive two e-mails: The first contains the final link to the seminar and the second contains the access data to a cloud folder in which you will find documents for preparation, exercises, and presentations.   

If the seminar or workshop takes place in person, you will also receive the access link to your seminar documents three days before the date of the event. We will also provide documents in digital form for in-person events.

The seminar takes place either in person or online.  

Our online/remote seminars and workshops are conducted via the video conferencing tool MS Teams. We recommend dialing in 20 minutes before the seminar begins so that any technical problems can be resolved in good time. If you have any questions or encounter any issues, our team is always available to help. 

We also recommend that you arrive at the seminar room approximately 20 minutes before the start of the face-to-face events.

At the end of the seminar, you will receive a feedback link for evaluation. The following day, we will send you your certificate of attendance.

If you experience technical problems while participating or have any other questions, you can contact our support team anytime, even at short notice. The documents provided also include an emergency number to help you in urgent cases. 

Our general FAQ section answers further technical and organizational questions.