Seminar "MDR in Detail"

The seminar covers the following topics: 

• MDR as the legal framework for medical devices in Europe 
• National implementation in Germany (MPDG) 
• Guidelines (MDCG, IMDRF, NBOG) and harmonized standards 
• Economic operators and their obligations, PRRC 
• Registration EUDAMED, UDI 
• Qualification and classification 
• General safety and performance requirements 
• Technical documentation 
• Conformity assessment procedures 
• Post-market surveillance and vigilance

After the seminar, you will know: 

• the regulatory framework for medical devices in Europe 
• the most important requirements for medical devices 
• the most important terminology 
• the steps for CE marking of a medical device for successful market access

This seminar is designed for people who want to gain a detailed overview of the regulatory framework for medical devices in Europe and learn about the most important requirements for placing medical devices on the EU market. 

Participants include: 

• Management, employees in regulatory affairs, quality management, research & development, and product management at medical device manufacturers 
• Employees who want to familiarize themselves with the applicable regulatory requirements for medical devices, e.g., PRRC according to Article 15, MDR 
• EU representatives, employees of supervisory authorities

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.