EU CE Mark and MDR
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I’m working on a health & medical question and need an explanation and answer to help me learn.
1. Historically, getting a CE mark and bringing a product to market in the EU was seen as straightforward, predictable, and the preferred geography to launch a product initially. Does the MDR change this perception? Why or why not? You may want to consider the U.S. FDA framework and trends in the least burdensome approach for getting a medical device to market in formulating an opinion. Additionally, you may want to comment on whether the development of the MDR was an appropriate response to the patient harm that resulted from the PIP scandal. This one is about 200 words.
2. With the adoption of EU MDR, can you think of 3 widely used medical device products that may require much higher scrutiny vs. the historical CE mark route? What are the factors causing stricter controls for these products? (No words limit as long as you finish answering the question.
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