The EU MDD is the directive that aims to harmonize the conditions governing the movement, the placing on the market and the bringing into service of medical devices throughout the internal market. The directive is based on the principles of the “New Approach to Technical Harmonization and Standards”. In line with this new approach, the design and manufacture of medical devices is subject to essential requirements concerning protection of the health and safety of patients and users of these devices. Medical devices must not compromise the clinical condition or the safety of patients. They also must not present any risk to the persons implanting them, or to other persons. These devices must achieve the performances intended by the manufacturer. They must be designed in such a way as to withstand the storage and transport conditions. Member States shall publish the national standards implementing the corresponding harmonized standards, which shall also include the monographs of the European Pharmacopoeia.
Member States shall assume that devices meet the essential safety requirements set out in this Directive where the devices comply with the national standards transposing the relevant applicable harmonized standards. All devices must be subjected to a conformity assessment procedure. Member States shall designate independent bodies contributing to the application of these procedures for devices other than those which represent a minimal risk. Member States shall take necessary steps to ensure that devices may be placed on the market and put into service only if they meet the requirements of this Directive and do not compromise the safety and health of patients, users and other persons when properly implanted, maintained and used in accordance with their intended purposes. Member States not must not impede the placing on the market, free movement and putting into service of devices meeting the essential safety criteria set out in the annexes to the Directive and bearing the CE mark.
