CE Marking for Medical Devices in Brazil
Trusted EU MDR & IVDR Compliance Support for Brazilian Manufacturers
Are you a medical device manufacturer in Brazil planning to export to Europe? To legally place your products on the European market, you must obtain CE Marking — proof that your device complies with EU safety, quality, and performance requirements. Operon Strategist supports Brazilian manufacturers in navigating EU MDR 2017/745 and IVDR 2017/746. From device classification to Notified Body coordination, we manage the complete CE Marking process, ensuring your device is fully compliant and ready for European commercialization.
What is CE Marking for Medical Devices?
CE Marking is a mandatory European conformity symbol that certifies your medical or IVD device meets EU regulatory standards.
For Brazilian manufacturers, CE Marking enables:
- Legal access to 30+ countries in the European Economic Area (EEA)
- International credibility and recognition of product safety
- Participation in EU tenders and reimbursement systems
- Regulatory approval under:
EU MDR 2017/745 – for general medical devices
IVDR 2017/746 – for in vitro diagnostic devices
Step-by-Step: CE Marking Process for Brazilian Manufacturers
- Classify Your Device – Identify correct risk category (Class I, IIa, IIb, III, or IVD A–D).
- Appoint a PRRC – Person Responsible for Regulatory Compliance (per EU MDR Article 15).
- Implement ISO 13485 QMS – With ISO 14971-based risk management.
- Prepare Technical Documentation – Including device specs, design files, CER, PMS plan, risk management reports.
- Supplier & Production Controls – Maintain traceability and quality standards.
- Conduct Clinical Evaluation – Demonstrate safety and performance using clinical data.
- Appoint EU Authorized Representative – Required for all Brazilian exporters.
- Coordinate with Notified Body – For Class IIa, IIb, III, and IVD B/C/D.
- Issue EU Declaration of Conformity (DoC) – Declare compliance with MDR/IVDR.
- Register in EUDAMED & Assign UDI – Meet EU traceability requirements.
- Affix CE Mark – Apply correct CE labeling on device and packaging.
- Post-Market Surveillance (PMS) – Collect real-world data and ensure ongoing compliance.
Let's Grow Your Business Together
Why CE Marking Matters for Brazilian Exporters
- Mandatory for EU Market Entry
- Proves Safety, Quality & Clinical Performance
- Boosts International Recognition
- Enables Insurance Reimbursement & Tender Access
- Strengthens Trust with Regulators & Stakeholders
CE Marking Services Tailored by Device Class
Class I Devices
- Self-certification support
- Technical documentation preparation
- Labeling & packaging compliance
- Post-Market Surveillance (PMS) planning
Class IIa & IIb Devices
- Clinical evaluation & risk-benefit analysis
- Notified Body submission
- Vigilance & PMS implementation
Class III Devices
- Clinical investigation guidance
- Expert panel consultation
- Comprehensive QMS documentation
In Vitro Diagnostic Devices (IVDs)
- Risk classification (A–D under IVDR)
- Performance evaluation support
- Annex II/III technical file preparation
- Notified Body coordination for Class B/C/D
- Post-market performance evaluation
Need CE Marking Support in Brazil? Contact Operon Strategist Now!
Why Choose Operon Strategist for CE Marking in Brazil?
Operon Strategist is a global regulatory consulting partner helping Brazilian medical device and IVD manufacturers achieve CE Marking under MDR & IVDR.
We provide end-to-end support, including:
- Device classification & regulatory strategy
- ISO 13485 QMS implementation
- Technical documentation & CER preparation
- Clinical evaluation & PMS setup
- Notified Body coordination
- EU Authorized Representative support
With over a decade of international consulting experience and collaborations with EU Notified Bodies, we ensure faster, cost-effective, and compliant CE Marking for Brazilian exporters.
Additional Regulatory Services by Operon Strategist
Beyond CE Marking, we assist global medical device manufacturers with:
- ANVISA Registration (Brazil)
- US FDA 510(k) Submission
- CDSCO Registration (India)
- SFDA Approval (Saudi Arabia)
- SAHPRA Registration (South Africa)
- EDA Compliance (Egypt)
We also specialize in:
FAQ'S
What is CE Marking and who needs it in Brazil?
Any Brazilian manufacturer exporting medical or IVD devices to Europe must obtain CE Marking for MDR/IVDR compliance.
How long does CE Marking take?
Typically 6–12 months, depending on device class and documentation.
Can you assist with Class III or IVD Class D devices?
Yes. We coordinate with Notified Bodies and provide expert regulatory guidance.
What are the CE Marking costs?
Costs vary depending on device type and Notified Body involvement. Request a custom quote.
Do I need an EU Authorized Representative?
Yes. Non-EU manufacturers, including those in Brazil, must appoint an EU Authorized Representative. Operon can assist.