IVDR Technical Documentation2025-09-12T03:26:25+05:30
IVDR Technical Documentation

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IVDR Technical Documentation

Under the new EU In Vitro Diagnostic Regulation (IVDR 2017/746), every IVD device placed on the EU market must have complete Technical Documentation (TD). This is required because:

  1. Demonstrates Compliance: It proves that the device meets General Safety and Performance Requirements (GSPR) outlined in IVDR Annex I.

  2. Notified Body Review and Approval: Without TD, the manufacturer cannot obtain or maintain CE Certification.

  3. Ensures Transparency & Traceability: Authorities, Notified Bodies, and Competent Authorities can review it during conformity assessments, audits, or inspections.

  4. Patient Safety & Performance: IVDR Technical Documentation includes risk management, performance evaluation, and analytical data to confirm that the device is safe and performs as intended.

  5. Regulatory Obligation: Article 10(4) of IVDR makes technical documentation mandatory for all manufacturers (whether self-certified or via a Notified Body).

Role of Consultants in IVDR Technical Documentation

Preparing IVDR Technical Documentation is complex, especially with stricter requirements compared to IVDD. Consultants help by:

  • Gap Assessment

    Reviewing existing files (IVDD-era files) and identifying missing elements needed for IVDR compliance.

  • Structuring the Documentation

    Organizing files per IVDR Annex II & III requirements (Device description, design & manufacturing, GSPR checklist, performance evaluation, PMS/PMCF plans, risk management, etc.).

  • Performance Evaluation

    Supporting in literature search, clinical data appraisal, and preparation of Performance Evaluation Report (PER).

  • Liaising with Notified Bodies

    Preparing documentation in the exact format expected, handling questions, and responding to review comments.

  • Reducing Regulatory Risk

    Ensuring that the documentation is audit-ready, avoiding costly delays or rejections

  • Training & Process Setup

    Helping manufacturers build internal capability for Post-Market Surveillance (PMS) and Periodic Safety Update Reports (PSUR) under IVDR.

Overall IVDR CE Marking Process

  1. Classify device (A, B, C, D).

  2. Implement ISO 13485 QMS.

  3. Prepare Technical Documentation & Performance Evaluation.

  4. Undergo Notified Body review + onsite audit.

  5. Obtain CE Certificate → Affix CE Mark → Maintain compliance via PMS.

service related FAQ’s

Responsibilities of US Agent?2025-07-31T14:14:34+05:30

Foreign manufactures and exporters interested in selling medical devices in the USA can approach us. Our extensive knowledge of FDA regulations will aid in a smooth and efficient registration process. We the US Agents awake and answer any time when authorities ask for information. In addition to our US office, we have offices in Germany, India, Malaysia, UK and Vietnam.

We are not just like others, we have a big team of device experts, consultants and project managers who can handle any type of service to your organization.

The US Agent Service is vital for FDA medical device registration of foreign medical and in-vitro diagnostic devices manufacturers and initial exporters.

Check the responsibilities of the US agents.

Can you help with Notified Body coordination or CE certification?2025-08-05T10:24:37+05:30

Absolutely. In addition to EC REP services, we offer end-to-end regulatory consulting, including Notified Body selection, technical file preparation, and gap analysis to support your CE Marking journey efficiently.

US FDA DMF2025-07-31T10:14:58+05:30

The drug Master Files are divided into 4 Types

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III: Packaging Material
Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V: FDA Accepted Reference Information

We provide US Agent service and E copy submission service. We also help with DMF preparation.

What happens if my device was previously CE marked under MDD?2025-08-03T08:58:14+05:30

All MDD-certified devices must transition to MDR compliance by the applicable deadline. Significant changes to the product or intended use may require a full MDR re-certification.

How quickly can I appoint your company as my EC REP?2025-08-05T10:26:16+05:30

We offer fast onboarding, typically within 1–2 working days upon receipt of the necessary documentation and agreement. We also guide you through label updates and document handovers to ensure a smooth transition.

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