Get CE Mark
Most SaMD is Class IIa or higher—requiring Notified Body involvement.
Key Steps:
- Prepare tech documentation (Annex II, III)
- Implement QMS (ISO 13485)
- Create clinical evaluation plan (CEP) and report (CER)
- 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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