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In order to be placed on the market, all Medical Devices except for devices in the lowest risk class must receive an assessment of conformity to Regulation (EU) 2017/745 (MDR) by a Notified Body. Notified Bodies are bodies designated by a Member State and operate according to the principles of independence, impartiality, and competence. In this chapter, we will explain the meaning of the CE marking, describe the characteristics of Notified Bodies, and illustrate the procedure for the conformity assessment that leads to the issuing of a CE certification. We will also describe the certification process according to the voluntary standard ISO 13485, which applies to manufacturers of Medical Devices but also to different organizations operating in the Medical Device sector.

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Medical Devices Certification Process in Europe

  • 章节

  • 出版模式：

    开放获取

  • 发表日期：

    2026年

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  • Armando Romaniello,
  • Pietro Iannì

摘要

In order to be placed on the market, all Medical Devices except for devices in the lowest risk class must receive an assessment of conformity to Regulation (EU) 2017/745 (MDR) by a Notified Body. Notified Bodies are bodies designated by a Member State and operate according to the principles of independence, impartiality, and competence. In this chapter, we will explain the meaning of the CE marking, describe the characteristics of Notified Bodies, and illustrate the procedure for the conformity assessment that leads to the issuing of a CE certification. We will also describe the certification process according to the voluntary standard ISO 13485, which applies to manufacturers of Medical Devices but also to different organizations operating in the Medical Device sector.