The new MDR promotes policies and procedures that raise the responsibilities of medical device manufacturers throughout the lifecycle of the device. Establishing a modernized and more robust legislative framework to ensure the protection of public health, the new rules aim to:
- Increase clinical investigation requirements and manage risk to ensure patient safety.
- Reinforce surveillance and management of the entire medical device life cycle.
- Improve transparency and traceability.
- Reduce ambiguity with clearer classifications and definitions.
The broader scope, extensive changes, and comprehensive measures of the MDR require a massive effort to overcome such a complex shift. The European market will observe conformity of all its commercialized medical devices by May 2024.
The DIH Group is committed to timely and thorough MDR compliance, ensuring the conformity and continued market availability of its devices that proudly improve lives, every day.