CE mark
of medical devices and IVDs
Certification for placing on the market
of medical devices and IVDs in the European Union
CE mark
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
- Determination of device classification (Class I, Is, Im, IIa, IIb, III)
- Preparation and structuring of the Technical Documentation (Annex II & III)
- Clinical Evaluation Plan (CEP) and Report (CER) drafting in compliance with MDCG guidance
- Risk Management File in accordance with ISO 14971:2019
- Usability Engineering (IEC 62366-1) and Software Life-Cycle documentation (IEC 62304)
- Coordination with Notified Bodies for conformity assessment procedures (Annex IX, X, XI)
- Preparation of Declaration of Conformity and 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
Do you have products that require CE marking?
We are here to assist you!
Fill out the form with your request.
We will contact you as soon as possible.
Contact form
