CE Marking & EU Device Registration

We manage CE marking as the defensible outcome of classification, conformity assessment, evidence, technical documentation, QMS and Notified Body review — not as a standalone administrative task.

Plan Your CE Marking Strategy

The Complete 10-Step CE Marking Sequence

Qualification

Classification

Conformity Assessment

Evidence & Testing

Technical Documentation

QMS / Notified Body

Declaration of Conformity

CE Marking Affixed

Registration / UDI

Lifecycle Compliance

CE Marking Compliance Deliverables

Conformity assessment route selection (Annex IX, X, XI)

Notified Body CE certification management & audit liaison

EU Declaration of Conformity (DoC) drafting and legal verification

CE mark graphic, labeling, IFU and symbol alignment (ISO 15223-1)

Basic UDI-DI and UDI-DI assignment & verification

EUDAMED actor registration & device registration data

Economic operator mandate review (Manufacturer, EC REP, Importer)

Ongoing CE certificate maintenance & annual renewal strategy

Expert Differentiator

Legally Binding Declaration of Conformity

The EU Declaration of Conformity is a solemn legal statement that the device meets all applicable Union harmonisation legislation. We ensure that every standard, certificate, Basic UDI-DI and GSPR referenced in your DoC is backed by unimpeachable technical evidence.

Market Entry Elements

• Notified Body Certificate of Conformity
• Appointed European Authorized Representative (EC REP)
• EUDAMED Single Registration Number (SRN)
• UDI-DI & UDI-PI compliant labeling

Ready for CE Marking?

Start your European market registration with senior regulatory leadership.

Initiate CE Marking

Achieve Seamless European CE Mark Clearance

Partner with NKB Regovanta for end-to-end conformity assessment and commercial launch support.

Book a Consultation