To whom is MDD 93/42/EEC directed?

MDD 93/42/EEC, which stands for the Medical Devices Directive, primarily serves as a regulatory framework aimed at ensuring the safety and effectiveness of medical devices across the European Union. The directive is directed toward EU Member States, as it sets out the legal obligations that these states must follow in their national laws regarding the marketing and use of medical devices.

While manufacturers, competent authorities, and notified bodies all play significant roles in the regulation and compliance of medical devices, the directive itself is a legal instrument that mandates EU Member States to implement the standards and procedures necessary to regulate these devices effectively. This includes ensuring that manufacturers comply with safety standards, facilitating the market entry of medical devices, and overseeing compliance through various bodies.

Therefore, the essence of the directive's direction towards EU Member States is crucial, as it emphasizes the role of national legislation in actualizing the directive’s provisions within their jurisdictions, which directly affects the industry and the manufacturers operating within the EU.