The MDR sets stringent requirements covering design, manufacturing, clinical evaluation and risk management, as well as traceability and post-market surveillance. Compliance with this regulation allows products to be legally marketed in the EU with a valid CE marking, confirming conformity with the applicable legislation.evaluation, and risk management, as well as traceability and post-market surveillance. Compliance with this regulation allows the products to be legally marketed in the EU with a valid CE marking, confirming conformity with applicable legislation.