To whom is the Medical Device Directive (MDD) 93/42/EEC primarily addressed?

The Medical Device Directive (MDD) 93/42/EEC is primarily addressed to EU Member States, as it establishes the framework for the regulation of medical devices within the European Union. The directive sets out essential requirements and procedures that member states must implement into their national laws to ensure that medical devices meet safety and performance standards before being placed on the market.

By addressing EU Member States, the MDD creates a harmonized approach to medical device regulation throughout the EU, allowing for mutual recognition of approvals and facilitating trade. This ensures that manufacturers in different countries can adhere to consistent safety and efficacy criteria, ultimately protecting public health.

While manufacturers are responsible for compliance with the directive's requirements, and Notified Bodies (NB) play a role in the conformity assessment process, the directive itself is designed to guide and be implemented by the EU Member States. Thus, the correct answer reflects the directive's focus on legislative requirements imposed on the countries within the EU rather than solely on manufacturers or regulatory bodies.