Partner for Expert Medical Device Regulatory Services in EU
The European Union offers one of the most advanced frameworks for medical devices and IVD compliance. Market access depends on a clear understanding of EU MDR, IVDR, CE Marking pathways, technical documentation requirements, UDI–EUDAMED submissions, and Post-Market Surveillance (PMS) obligations.
DDReg provides strategic, structured, and execution-driven support across EU Medical Device Registration, EU MDR consulting services, IVDR compliance, and Medical Device CE Marking Services. Our expertise supports medical device and IVD manufacturers seeking market entry and long-term regulatory compliance across all EU-27 countries, including guidance from experienced EU MDR registration consultant, IVDR consultant, and EU medical device classification consultant.
Why Do Manufacturers Choose DDReg for EU Medical Device Registration?
- Accurate medical device and IVD classification support aligned with MDR/IVDR rules
- Evidence-based guidance for CE Marking and conformity assessment
- End-to-end dossier preparation and Notified Body communication
- Practical compliance support for EUDAMED, UDI, vigilance, and PMS
- Support for both new product registration and MDD/MDR transition projects
- Dedicated expertise across Class I–III devices and Class A–D IVDs
Regulatory Framework for Medical Device Registration in the EU
- Revised classification rules
- Increased clinical evidence requirements
- Mandatory Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF)
- Strict quality and technical documentation expectations
Applies to IVDs and includes:
- Risk-based classification
- Performance evaluation expectations (scientific validity, analytical & clinical performance)
- EUDAMED registration and reporting
- Strengthened oversight by Notified Bodies
| Category | Classification Levels | Notified Body Required | Examples |
|---|---|---|---|
| Medical Devices | Class I, IIa, IIb, III | Required for IIa–III | Surgical instruments, implants, diagnostics |
| IVD Devices | Class A, B, C, D | Required for B–D | Companion diagnostics, molecular tests |
Accurate classification influences dossier complexity, pathway, clinical expectations, and approval timelines. DDReg supports classification and regulatory strategy from the start.
Our Core EU Medical Devices Regulatory Service Capabilities
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EU Medical Device Classification and Regulatory Strategy
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Technical Documentation & Dossier Preparation
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CE Marking and Conformity Assessment Support
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EUDAMED and UDI Registration Services
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Post-Market Surveillance (PMS) and Vigilance Compliance
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EU Authorised Representation & Lifecycle Management
Who We Support
- Medical device manufacturers
- IVD and diagnostic companies
- Digital health and software-as-a-medical-device (SaMD) innovators
- Organisations transitioning from MDD/AIMDD to MDR or IVDD to IVDR