CE Marking for Medical Devices — Simplified
CE marking (Conformité Européenne) is the mandatory European conformity marking that indicates a medical device meets the safety, health, and environmental protection requirements set out in EU MDR 2017/745 (for medical devices) and EU IVDR 2017/746 (for in vitro diagnostics).
In simple terms: without CE marking, your medical device CANNOT legally be sold in the EU, EEA, or countries that accept CE-marked products.
CE marking (Conformité Européenne) is the mandatory European conformity marking that indicates a medical device meets the safety, health, and environmental protection requirements set out in EU MDR 2017/745 (for medical devices) and EU IVDR 2017/746 (for in vitro diagnostics).
In simple terms: without CE marking, your medical device CANNOT legally be sold in the EU, EEA, or countries that accept CE-marked products.
CE marking is not a quality mark — it is a legal obligation and a regulatory declaration by the manufacturer that the device meets all applicable EU regulatory requirements. CE marking is required for all medical devices placed on the EU/EEA market — whether manufactured inside or outside the EU.
Our Approach to CE Marking
We simplify the CE marking process for medical devices
Discovery & Assessment
We begin with a thorough review of your device, intended use, and target markets.
Strategy & Planning
Our team builds a tailored regulatory strategy with clear milestones and timelines.
Submission Preparation
We prepare all technical documentation and submission packages to the highest standards.
Our Services
| Regulatory Framework | RABT Global Services |
|---|---|
| EU MDR 2017/745 | CE marking for medical devices |
| EU IVDR 2017/746 | CE marking for in vitro diagnostics |
Our Key Services
We offer a range of services to support your CE marking journey
CE Marking for Medical Devices
We provide expert guidance on CE marking for medical devices, ensuring compliance with EU MDR 2017/745.
CE Marking for In Vitro Diagnostics
We provide expert guidance on CE marking for in vitro diagnostics, ensuring compliance with EU IVDR 2017/746.
Why Choose RABT Global?
We have extensive experience in CE marking for medical devices and in vitro diagnostics, and our team of experts will guide you through the process with ease.
Frequently Asked Questions
CE marking is the mandatory European conformity marking that indicates a medical device meets the safety, health, and environmental protection requirements set out in EU MDR 2017/745 (for medical devices) and EU IVDR 2017/746 (for in vitro diagnostics).
CE marking is required for all medical devices placed on the EU/EEA market — whether manufactured inside or outside the EU.
Get Started with CE Marking
Our team of experts will guide you through the CE marking process with ease. Contact us today to learn more.