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 regulation regarding medical devices in the EU?
- What is the impact of the MDR on the clinical investigation activities?
After this training you will be able to:
- Indicate when something is a medical device or not
- Name the individual ingredients needed to place a medical device on the market
- Identify the applicable laws and regulations for medical devices
- Mapping the changes that the new regulation for medical devices entails
- Understand the differences between clinical evaluation and clinical investigation
- Comprehend the different types of regulatory pathways for obtaining regulatory approval of clinical investigations in Europe and The Netherlands
- Understand which documents are needed for the application from start to finish
- Identify the requirements during and after study conduct
Register for this training
Time: 1 full day from 9:30 am till 4:30 pm CET
Target group: this training lays the foundation for manufacturers and professionals who engage in clinical research with medical devices, and 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 (At location in Utrecht, The Netherlands is optional)
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.