The CE Marking Process for SaMD

ByPiotr Wrzosinski

Get CE Mark

Most SaMD is Class IIa or higher—requiring Notified Body involvement.

Key Steps:

  1. Prepare tech documentation (Annex II, III)
  2. Implement QMS (ISO 13485)
  3. Create clinical evaluation plan (CEP) and report (CER)
  4. Work with a Notified Body

Class-specific routes:

  • Class I: self-certify
  • Class IIa-III: Notified Body review + ongoing surveillance

This post is part of SaMD Europe Launch Guide.

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Piotr Wrzosinski

Piotr Wrzosinski is a life sciences commercial and digital transformation leader with 20+ years of experience across pharma, medtech, and consulting. He writes about medtech, digital health, commercialization, AI, and regulation in Europe through an operator lens focused on adoption, evidence, and scale.