MDD 93/42/EEC
What is MDD 93/42/EEC?
MDD 93/42/EEC refers to the Medical Device Directive 93/42/EEC, a directive issued by the European Economic Community concerning medical devices. It sets out the regulatory requirements for medical devices to be placed on the market in the European Union. It covers a wide range of devices, from simple bandages to complex equipment like pacemakers, ensuring they meet safety and performance standards. The directive outlines essential requirements related to design, manufacturing, labeling, and clinical evaluation. Manufacturers must demonstrate compliance through conformity assessment procedures, often involving notified bodies, to obtain CE marking, which allows them to legally market their devices within the EU. The Medical Device Regulation (MDR) 2017/745 has replaced the MDD 93/42/EEC.
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