About this document
Overview of MDD 93/42/EEC Compliance by hakurenjo is a document available to read on EtoBox.
The document discusses the key aspects of the Medical Device Directive (MDD) 93/42/EEC for medical devices in Europe. It covers the objectives of harmonizing regulations while ensuring safety and manufacturer responsibility. It also summarizes the conformity assessment procedures and classification rules for medical devices, as well as requirements for CE marking, use of standards like ISO 13485, and the role of Notified Bodies in the process.
- Author
- hakurenjo
- Language
- EN