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Home » EU MDR: Broad Regulatory Framework Creates Compliance Challenges
EU MDR: Broad Regulatory Framework Creates Compliance Challenges
September 7, 2022
One year into implementation, the EU Medical device regulation (MDR) is undergoing some growing pains. A number of new developments have arisen to challenge devicemakers learning how to comply with the new regulation. These developments include introductions of new guidances, new harmonized standards and common specifications, plus different interpretations offered by the Medical Device Coordinating Group (MDCG).