CE Marking for Medical Devices

CE Marking is mandatory for medical devices sold in the European Union under EU MDR 2017/745. LMG provides CE Marking consulting alongside FDA registration services for manufacturers entering both markets.

EU MDR 2017/745Notified BodyTechnical FileSince 2009

CE Marking Consulting for Medical Devices

CE Marking is the regulatory conformity marking required for medical devices sold in the European Union under EU Medical Devices Regulation (EU MDR 2017/745) and In Vitro Diagnostic Regulation (EU IVDR 2017/746).

CE Marking demonstrates that the device meets EU safety and performance requirements. Most Class II and Class III medical devices require assessment by a Notified Body.

LMG is a globally recognized FDA, CE Marking, and ISO consulting firm. We provide CE Marking consulting alongside FDA registration services for manufacturers entering both the US and European markets.

EU MDR 2017/745 compliance assessment
Technical documentation and Technical File preparation
Clinical evaluation (clinical data, PMCF plan)
Notified Body support (selection, submission, communication)
ISO 13485 QMS consulting
Post-Market Surveillance (PMS) and PMCF planning

Frequently Asked Questions

Common questions about this FDA label compliance service.

What is CE Marking?

CE Marking is a mandatory conformity marking for medical devices entering the European market, demonstrating compliance with EU MDR 2017/745 requirements.

Is CE Marking required for all medical devices in Europe?

Yes. All medical devices placed on the EU market must bear the CE Mark.

Does LMG provide both FDA and CE Marking consulting?

Yes. LMG provides both FDA registration and CE Marking consulting — ideal for manufacturers entering both the US and European markets.