CE Marking & MDR Certification – Gateway to the European Medical Device Market

What is CE Marking / MDR Certification?

CE Marking is a mandatory conformity mark for products sold in the European Economic Area (EEA). For medical devices, CE Marking is governed by the Medical Device Regulation (EU) 2017/745, also known as MDR.

CE Marking under MDR confirms that a medical device meets EU safety, health, and performance requirements and can be freely marketed across EU countries. It is a legal obligation for manufacturers, importers, and distributors of medical devices in Europe.

Why MDR and CE Marking Matter

The MDR replaces the previous Medical Device Directive (MDD) and introduces stricter controls, increased transparency, and robust post-market surveillance. CE Marking under MDR shows that your product complies with one of the highest global standards for patient safety and quality.

Key Benefits of CE Marking (MDR):

  • Legal access to EU markets (27+ countries)

  • Builds confidence with healthcare professionals and patients

  • Expands global trade opportunities

  • Ensures traceability, safety, and performance of medical devices

  • Boosts credibility for tenders and hospital procurement

What Devices Need MDR CE Marking?

The MDR applies to all medical devices, including:

Device Type Examples
Class I (low risk) Bandages, wheelchairs, reading glasses
Class IIa/IIb (medium risk) Surgical instruments, infusion pumps
Class III (high risk) Pacemakers, heart valves, implantable devices
Custom-made Devices Prosthetics, dental appliances
Software as a Medical Device (SaMD) Health monitoring apps, diagnostic software

CE Marking / MDR Certification Process

  1. Product Classification – Determine your device’s risk class under MDR

  2. Technical Documentation – Prepare a comprehensive Technical File and Declaration of Conformity

  3. Quality Management System (QMS) – Implement ISO 13485-based QMS

  4. Notified Body Involvement – Required for all but Class I non-sterile/non-measuring devices

  5. Clinical Evaluation – Conduct performance and safety assessments

  6. Post-Market Surveillance – Set up systems for ongoing monitoring and reporting

  7. CE Mark Affixing – Apply the CE logo and register in EUDAMED (European database)

Our CE Marking (MDR) Support Services

We provide full guidance and support throughout your CE certification journey:

  • Technical documentation preparation

  • Risk assessment and clinical evaluation support

  • ISO 13485 QMS implementation

  • Liaison with Notified Bodies

  • Gap analysis and mock audits

  • Post-certification compliance and vigilance support

Ready to Launch Your Medical Device in the EU?

Don’t risk delays or rejection in the EU market. Let us help you achieve MDR-compliant CE Marking with confidence and efficiency.

Contact us today to schedule a free consultation and take the next step toward MDR CE certification.