Medical Device Regulation (MDR) & The Clinical Landscape

  • What is a medical device?
  • What is needed to put a medical device on the market?
  • Why is clinical research performed with medical devices?
  • Which laws and regulations apply to medical devices?
  • What has changed with the arrival of the new Medical Device Regulation in the EU?
  • What are the differences between clinical evaluation and clinical investigation? 
  • What are the different types of regulatory pathways for obtaining regulatory approval of clinical investigations?
  • Which documents are needed for the application from start to finish?
  • What are the requirements during and after study conduct?

These are important issues to which I will provide answers in the most practical way possible. So that after following this training you have not only obtained the answers, but through exercises and practical examples, you are also able to apply the acquired knowledge and translate it into practice, tailored to your situation.

After this training you will be able to:

  1. Indicate when something is a medical device or not
  2. Identify the individual ingredients needed to place a medical device on the market
  3. Identify the applicable laws and regulations for medical devices
  4. Mapping the changes that the new regulation for medical devices will entail
  5. Understand the differences between clinical evaluation and clinical investigation
  6. Comprehend the different types of regulatory pathways for obtaining regulatory approval of clinical investigations
  7. Understand which documents are needed for the application from start to finish
  8. Identify the requirements during and after study conduct

Register for this training

By clicking on “register” below, you will see the training dates.

You can enter your details by clicking on the available date.

After receiving your payment, you are registered, and you will immediately receive the invoice.

Practical information:

Time: 1 full day from 9:30 a.m. to 4:30 p.m. CET incl. lunch

Target group: this training lays the foundation for manufacturers and professionals who engage in clinical research with medical devices, even if you already have experience with ICH-E6 (R2) Good Clinical Practice

Price: €595,- excluding VAT, per participant

Number of participants: min. 6, max. 12

Certificate: certificate of participation

Location: Online live session

Language: the training is provided in Dutch or English. Please indicate in advance if you require the English-language version of the training. The course material is in English.

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