Medical Device Regulation (MDR)

What is a medical device?
What does it take to put your medical device on the market?
What laws and regulations apply to medical devices?
What has changed with the arrival of the new regulation for medical devices in the EU?

Valuable questions to which I will give the answer in the most practical way possible. So that after following this training you not only have obtained the answers, but also through exercises and practical examples you are able to apply the acquired knowledge and to translate it into the reality that applies to you.

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

Sign up for this training

By clicking on “register” below, you can see on which days this training is given.

By clicking on the available day, you can enter your details.

After receipt of payment you are registered and you will also receive the invoice immediately.

“Before this training I found interpreting MDR could be overwhelming and confusing, however Rianne's training provides you with a great overview of the legislation and breaks it down into clear and manageable sections”

”The materials, used during the training, are concise and such a large subject was presented lightly, which I think is impressive“

”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!“

Practical information:

Time: half a day from 9:30 am till 1:30 pm CET

Target group: this training lays the foundation for manufacturers and professionals who
work with medical devices

Price: €324,- 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 given in Dutch or English. Choice for an English-taught training must be indicated in advance. The course material is in English.

“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”

”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“

”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!“

“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.”