EU IVDR CE Registration Service
EU IVDR market-access support for Class A–D in vitro diagnostic devices, including conformity-route planning, technical documentation, QMS coordination and notified-body interaction where required. Routes are organized by risk class and conformity-assessment approach.
Choose an option
Service Overview
EXIMIO supports IVD manufacturers preparing for CE market access under the EU IVDR. The product combines the six source workflows into one service page so customers can select the correct class and conformity-assessment route without duplicating nearly identical product pages.
Process Flow & Timing
Select a route below to view the workflow and timing.
Class A
Indicative source timeline~90 days non-sterile · longer for sterileSource estimate; not statutory
EU IVDR Class A Registration
Appoint PRRC
Performance Evaluation / PMS / PMPF
Maintain QMS
Class A — Non-Sterile
Technical Documentation
EU Authorized Representative
Declaration of Conformity
Obtain UDI
Registration Approved
Class A — Sterile
Technical Documentation
ISO QMS / Sterile Controls
Notified Body (Sterile Aspects)
Declaration of Conformity
Obtain UDI
Registration Approved
Class B
Indicative source timeline90–180 daysSource estimate; not statutory
EU IVDR Class B Registration
Appoint PRRC
Professional-Use IVD
ISO QMS
Product Technical Documentation
Performance Evaluation
Self-Test / Near-Patient IVD
Administrative Requirements
Product Technical Documentation
ISO QMS
Technical Documentation Evaluation
EU Authorized Representative
Notified Body Assessment
CE / ISO Certificates
Declaration of Conformity
Obtain UDI
Registration Approved
Class C – QMS + Technical Documentation
Indicative source timeline90–180 daysSource estimate; not statutory
EU IVDR Class C — QMS + Technical Documentation
Appoint PRRC
Professional-Use IVD
ISO QMS
Product Technical Documentation
Administrative Requirements
Self-Test / Near-Patient IVD
Administrative Requirements
Product Technical Documentation
ISO QMS
Technical Documentation Evaluation
EU Authorized Representative
Notified Body Assessment
CE / ISO Certificates
Declaration of Conformity
Obtain UDI
Registration Approved
Class C – EC Type Examination + Production QA
Indicative source timeline90–180 daysSource estimate; not statutory
EU IVDR Class C — EC Type Examination + Production QA
Appoint PRRC
Professional-Use IVD
ISO QMS
Product Technical Documentation
Administrative Requirements
Self-Test / Near-Patient IVD
Administrative Requirements
Product Technical Documentation
ISO QMS
EC Type Examination
Type-Examination Certificate
Production Quality-Assurance Certificate
EU Authorized Representative / Notified Body
Declaration of Conformity
Obtain UDI
Registration Approved
Class D – QMS + Technical Documentation
Indicative source timeline90–180 daysSource estimate; not statutory
EU IVDR Class D — QMS + Technical Documentation
Appoint PRRC
Professional-Use IVD
ISO QMS
Product Technical Documentation
Administrative Requirements
Self-Test / Near-Patient IVD
Administrative Requirements
Product Technical Documentation
ISO QMS
Technical Documentation Evaluation
EU Authorized Representative
Notified Body / Class D Assessment
CE / ISO Certificates
Declaration of Conformity
Obtain UDI
Registration Approved
Class D – EC Type Examination + Production QA
Indicative source timeline90–180 daysSource estimate; not statutory
EU IVDR Class D — EC Type Examination + Production QA
Appoint PRRC
Professional-Use IVD
ISO QMS
Product Technical Documentation
Administrative Requirements
Self-Test / Near-Patient IVD
Administrative Requirements
Product Technical Documentation
ISO QMS
EC Type Examination
Type-Examination Certificate
Production Quality-Assurance Certificate
EU Authorized Representative / Notified Body
Declaration of Conformity
Obtain UDI
Registration Approved
Regulatory Basis & Official References
Legal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.
LawRegulation (EU) 2017/746 (IVDR)Official Journal legal act; use Article 47 (classification), Article 48 (conformity assessment), Annex VIII and Annexes IX–XI for the routes shown.Open official source ↗LawIVDR — current consolidated textConsolidated IVDR text current to 10 January 2025 on EUR-Lex.Open official source ↗
Related Regulatory Support
EU Authorized Representative coordination, QMS preparation, performance-evaluation documentation, UDI support and technical-document review can be included in the project scope.
EXIMIO Support
Contact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.