MDR

For manufacturers of medical devices

Description

The Medical Device Regulation (MDR) imposes extensive requirements on all medical devices marketed in Europe. For example, the MDR requires medical devices placed on the European market to be CE marked as proof that the product complies with the applicable regulations. The CE marking verifies that they meet the necessary safety and performance standards.

Compliance with the MDR is an important part of ensuring the highest possible protection for both users and patients. For manufacturers, it is crucial to understand both the specific requirements and the process for achieving and maintaining CE marking, which includes everything from product development to aftermarket control.

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