EU MDR CE Marking & Technical Documentation

Navigating the European Union Medical Device Regulation (EU MDR) can be complex — but HeurNova Consulting simplifies the path from concept to certification. Whether you’re preparing a new submission, updating legacy files, or responding to Notified Body feedback, we meet you at your current stage of compliance. Our EU MDR support services encompass everything from Strategic Gap Assessments and Classification Mapping to comprehensive Technical Documentation (Annex II & III) development and alignment.

We guide you through the CE Marking process with structured documentation frameworks that integrate seamlessly with your Quality Management System, ensuring full traceability from design inputs to post-market activities. Our team helps harmonize procedures across ISO 13485 and MDR expectations, delivers expert guidance on clinical evaluation and risk documentation, and provides readiness audits to ensure your submission is inspection-ready.

No matter where you are in your regulatory journey, we help you establish a compliant, audit-ready foundation — positioning your products and organization for successful CE certification and long-term market confidence.

Regulatory Strategy

Would you like to ensure your medical device follows the correct regulatory pathway from the start? Our Regulatory Strategy and Classification service defines the optimal approach for CE marking by assessing your device’s intended use, risk class, and applicable conformity routes. We evaluate relevant directives, guidance documents, and harmonized standards to justify your classification under EU MDR (2017/745), ensuring a compliant foundation for technical documentation and submission success.

We help you determine the right regulatory pathway for your device under the EU MDR (2017/745). We can help define your product's intended use, and align it with the appropriate conformity route. We also identify applicable harmonized standards and outline a roadmap to CE marking, ensuring every step meets regulatory expectations.

Deliverables we can provide include, but are not limited to:

MDR applicability assessment (EU 2017/745 vs. 2017/746)
Borderline and combination product analysis
Intended use definition and regulatory pathway strategy
Identification of relevant harmonized standards and guidance

Technical Documentation (Annex II & III)

Need support compiling audit-ready documentation that meets MDR expectations? We prepare comprehensive technical files structured to the requirements of MDR Annex II and III. Each section — from device description and design verification to clinical evaluation and post-market surveillance — is developed for consistency, completeness, and traceability. The result is a robust submission package that meets Notified Body and regulatory standards across all product types.

We compile and structure your Technical Documentation in compliance with MDR Annex II and III. This includes creating or refining device descriptions, GSPR checklists, design and manufacturing documentation, validation summaries, labeling, and risk management files. We ensure your documentation is organized for smooth notified body review.

Deliverables we can provide include, but are not limited to:

Technical File compilation or review
Device description and specification
Design and manufacturing information
General Safety and Performance Requirements (GSPR) checklist
Risk management file (ISO 14971)
Verification and validation evidence
Clinical evaluation report (CER)
Post-market surveillance (PMS) and PMCF plans/reports
Labeling, IFU (Instructions for Use), and UDI compliance

Testing & Performance Evaluation (Advisory)

Do you need guidance determining which testing and validation activities are required for CE compliance?

While we do not perform laboratory testing, we prepare and guide your team through all test requirements. This includes identifying necessary biocompatibility, electrical safety, usability, or sterilization validations per ISO and IEC standards. We connect you with accredited laboratories and help interpret their reports to ensure they meet MDR expectations.

Deliverables we can provide include, but are not limited to:

Biocompatibility testing (ISO 10993 series)
Electrical and mechanical safety (IEC 60601-1)
Software validation and cybersecurity (IEC 62304, 81001-5-1)
Usability engineering (IEC 62366)
Shelf-life and packaging validation
Sterilization validation and residuals analysis
Chemical, physical, and microbiological testing

Quality Management System (QMS) Compliance

Would you like to ensure your QMS fully aligns with MDR’s evolving requirements? We adapt and harmonize your existing Quality Management System with MDR expectations, integrating device-specific documentation, PMS linkages, and traceability requirements. Our approach builds on your ISO 13485 framework to maintain conformity, inspection readiness, and sustainable compliance throughout the product lifecycle.

We support implementation, optimization, and harmonization of your Quality Management System to meet ISO 13485:2016 and MDR requirements. Our services include document control setup, internal audit preparation, supplier management procedures, and management review templates—everything your team needs to stay compliant and audit-ready.

Deliverables we can provide include, but are not limited to:

ISO 13485:2016 implementation or gap closure
Quality manual and procedures development
Document control and record retention systems
Supplier and purchasing controls
Internal auditing and management review support
Integration of MDR-specific QMS requirements

Risk Management & Usability

Want to strengthen your product’s safety and performance documentation? Our Risk Management and Usability service integrates ISO 14971 risk processes with usability evaluations under IEC 62366. We help identify, assess, and mitigate potential hazards while ensuring all control measures are traceable, effective, and supported by verification evidence within your technical documentation.

We develop comprehensive risk management documentation aligned with ISO 14971. This includes identifying hazards, conducting FMEA, and creating risk-benefit analyses. For usability, we guide your team in planning and documenting usability evaluations in accordance with IEC 62366, ensuring safe and intuitive device operation.

Deliverables we can provide include, but are not limited to:

Risk analysis and mitigation per ISO 14971
Human factors engineering documentation
Failure Mode and Effects Analysis (FMEA)
Fault tree and hazard analysis

Post-Market Services

Need help maintaining post-market compliance under MDR? We assist with post-market surveillance, and vigilance activities. Our support includes literature reviews, PMS and PMCF plan development, and preparation of SSCPs and PSURs. We help you interpret feedback from clinical use and integrate it into continual compliance.

Deliverables we can provide include, but are not limited to:

PMS plan, PMCF plan, and PSUR/SSCP preparation
Vigilance reporting and CAPA management

Labeling, UDI & Supply Chain Compliance

Would you like confidence that your labeling and supply chain fully meet MDR and EUDAMED requirements? We review, standardize, and align labeling, IFUs, and UDI systems to ensure consistency and traceability throughout your supply chain. Our service also helps manufacturers, authorized representatives, importers, and distributors meet their respective regulatory obligations under MDR, maintaining full transparency and compliance from production to market distribution.

We review labeling and IFUs for MDR conformity and coordinate multilingual translations as needed. We also guide you through the UDI registration process in EUDAMED and ensure compliance across all economic operator roles—manufacturer, authorized representative, importer, and distributor.

Deliverables we can provide include, but are not limited to:

Label and IFU conformity to MDR Annex I
Translation management for EU markets
UDI registration (EUDAMED)
Economic operator roles: Manufacturer, AR, Importer, Distributor

Get a Quote

Every organization's compliance journey is different — your quote should be too.

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