Module11 April 20264 min read
Module spotlight: CE Marking & Declarations of Conformity
The CE mark and the declaration of conformity are your formal statement that a product meets the rules. These modules keep that statement accurate and backed by evidence.
By MoniDoseQMS Team
Placing a product on the EU market ends with a formal commitment: the declaration of conformity and the CE mark, your legal statement that the device meets the applicable requirements. These modules keep that statement accurate and traceable to the evidence behind it.
What you can do
- Manage CE marking procedures
- Produce and maintain declarations of conformity
- Connect declarations to the technical documentation that supports them
- Keep essential requirements (GSPR) mapped and evidenced
Why it matters
EU MDR (Articles 19-20) makes the declaration of conformity and CE marking the formal endpoint of conformity assessment. Keeping them linked to the technical file means the declaration always reflects the current, evidenced state of the device.