our approach aimed at maximizing productivity & efficiency.
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:
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Demonstrates Compliance: It proves that the device meets General Safety and Performance Requirements (GSPR) outlined in IVDR Annex I.
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Notified Body Review and Approval: Without TD, the manufacturer cannot obtain or maintain CE Certification.
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Ensures Transparency & Traceability: Authorities, Notified Bodies, and Competent Authorities can review it during conformity assessments, audits, or inspections.
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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.
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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:
Overall IVDR CE Marking Process
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Classify device (A, B, C, D).
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Implement ISO 13485 QMS.
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Prepare Technical Documentation & Performance Evaluation.
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Undergo Notified Body review + onsite audit.
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Obtain CE Certificate → Affix CE Mark → Maintain compliance via PMS.
service related FAQ’s
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.
Yes we provide Food, Cosmetic, Drug and cosmetic label review service.
https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
https://www.fda.gov/drugs/development-resources/labeling-information-drug-products
Absolutely. We can take over PMCF activities for devices already CE-marked and on the EU market, ensuring that your data collection, evaluation, and reporting fully meet MDR requirements — even if your existing documentation needs corrective action before the next Notified Body audit.
As part of our commitment to regulatory compliance and risk management, we recommend that all non EU manufacturers have valid Product Liability Insurance when appointing us as their European Authorized Representative (EC REP). While it is not a legal requirement under MDR/IVDR for the EC REP to request proof of insurance, many Competent Authorities and Notified Bodies may inquire about the manufacturer’s liability coverage during inspections or audits. Having proper insurance also demonstrates due diligence and protects your business in the event of product-related claims in the European market. We do not provide insurance ourselves, but we can guide you on what to include based on your device risk class and market exposure.
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.
