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?
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:
- 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
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.
“Valuable training which started with a good overview of the MDR, nice practical exercises regarding classification of medical devices and a fun knowledge check game regarding the content presented”
Roche Nederland
”Aspects that were most valuable for us as a clinical trial manager were the clinical implications, vigilance and safety reporting and the different legal frameworks for clinical investigations under the MDR“
Roche Nederland
”Rianne knows how to give a good high level overview of the MDR with a deep dive into the parts that are applicable to the clinical research department of our company!“
Roche Nederland
“We now have a good understanding of the terminology and the different pathways to follow. In case of a medical device trial, we are now capable to follow flowcharts and decision trees in order to create a strategy according to the MDR.”
Roche Nederland
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Practical information:
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: €649,- excluding VAT, per participant
Number of participants: min. 3, 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.