CE Marking
Enter the European market with compliance
CE Marking for the European Union
To place a medical device on the European Union market, manufacturers must comply with the EU Regulation (EU) 2017/745 (MDR) or 2017/746 (IVDR).
ALTRION provides end-to-end support for CE marking, from Technical Documentation preparation to Notified Body coordination and Post-Market Surveillance (PMS) management.
Our Services
Regulatory Classification
- Determination of device classification (Class I, Is, Im, IIa, IIb, III)
Technical Documentation
- Preparation and structuring of the Technical Documentation (Annex II & III)
Clinical Evaluation
- Clinical Evaluation Plan (CEP) and Report (CER) drafting in compliance with MDCG guidance
Risk Management
- Risk Management File in accordance with ISO 14971:2019
Usability & Software Compliance
- Usability Engineering (IEC 62366-1)
- Software Life-Cycle documentation (IEC 62304)
Conformity Assessment
- Coordination with Notified Bodies for conformity assessment procedures (Annex IX, X, XI)
Regulatory Representation
- Preparation of Declaration of Conformity
- EU Representative (EU-REP) designation
Post-Market Activities
- PMS Plan
- PSUR
- PMCF
- Vigilance
Why Choose Altrion
- Over 15 years of experience in MDR transition and EU conformity assessments
- Multilingual team supporting documentation in EN, FR, IT
- In-depth experience with Class I–III devices, IVDs, and software (SaMD)
- Seamless coordination between EU manufacturer, EU-REP, and Notified Body
Deliverables
- Complete CE Technical Documentation compliant with MDR/IVDR
- EU Declaration of Conformity
- Support during Notified Body review and audit follow-up
- PMS and vigilance strategy documentation
Contact Us
Fill in the form and we will get back to you as soon as possible.