What is CE Marking for medical device?
CE Marking indicates that a medical device complies with the requirements of the European Union Medical Device Regulation (EU MDR 2017/745). Depending on the device classification, compliance is demonstrated either through manufacturer self-declaration (for eligible Class I devices) or conformity assessment by a Notified Body. CE Marking allows the device to be legally marketed throughout the European Economic Area (EEA).
When Do You Need MDR Support
and What Are the Key Challenges?
From new device launches to MDR transition, we help you navigate complex regulations and achieve compliance with confidence.
When Do You Need
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Launching a medical device in the European Economic Area (EEA)
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Transitioning from old MDD/AIMDD certificates to MDR
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Major changes to device design or intended use
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Addressing major non-conformities raised by Notified Body
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Lack of an internal regulatory team
Key Challenges
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MDR classification complexity
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Clinical evidence requirements
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Limited availability of Notified Bodies
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EUDAMED registration requirements
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UDI implementation
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Supplier qualification
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PMS & PMCF obligations
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Legacy MDD to MDR transition
MDR Compliance Roadmap and Deliverables
A clear, practical process that closes MDR gaps, strengthens documentation, and prepares your device for a smoother regulatory submission.
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Submission-ready Technical File / Design Dossier
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Clinical Evaluation Report (CER) & PMCF Plan
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Post-Market Surveillance (PMS) Plan & Report
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MDR Article 32 mandates an SSCP for Class III and implantable devices.
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Gap Analysis Report
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Risk Management File (RMF)
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General Safety and Performance Requirements (GSPR) checklist
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Unique Device Identification (UDI) support
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Labelling and Instructions for Use (IFU) review
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Gap assessment against MDR 2017/745
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Customized regulatory roadmap
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Build or rewrite Technical File
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Liaison with Notified Body for efficient communication
Regulatory Support That Moves You Forward
Built for startups and growing medtech companies that need a practical, low-burden pathway to compliance.
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Focus on startup-friendly regulatory pathways
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End-to-end documentation and labelling support
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Skilled in managing Notified Body queries
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Challenge: Startup struggled 1.5 years with MDR pathway, clinical evidence, and documentation
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Mapped product to MDR classification rules
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Designed lean, low-burden conformity route
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Developed an MDR-compliant clinical evidence approach by evaluating clinical data, literature, and post-market strategies.
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Clear regulatory pathway, Technical File aligned to Notified Body expectations, accelerated product launch.
Our Approach:
Outcome:
FAQ
Frequently Asked Questions
The timeline depends on the device classification and readiness of documentation. It can range from a few months to more than a year.
Key documents include Technical File, Clinical Evaluation Report (CER), Risk Management File (RMF), and PMS documentation.
CE consultancy for medical devices helps manufacturers navigate EU MDR requirements, avoid delays, and achieve successful certification.
Yes, CE marking is mandatory for medical devices to be legally marketed in the European Economic Area.
Certain Class I non-sterile, non-measuring devices and non-reusable surgical instruments may undergo manufacturer self-declaration. Most Class IIa, IIb, and III devices require Notified Body involvement.
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