Lecture 5 - Medical Devices and Biomaterials

Question 1

Draw a tree diagram showing the different non invasive devices.

Answer 1

Question 2

Give different medical devices that fit into the different medical device configurations.

Answer 2

Question 3

What is the generalised MDR(EU) 2017/745 definition for a ‘medical device’?

Answer 3

• ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended to be used for humans for any of the following:
• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, investigation, replacement or modification of the anatomy.
• Not a drug or pharmaceutical agent.