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
The timeline varies based on device class and documentation readiness. Class I devices may take a few weeks, while Class IIa, IIb, and III devices requiring Notified Body review may take 6–12 months or more.
- Improved Document Control
- Effective Audit Management
- Better Employee Training Programs
- Better Risk Management
- Efficient Tracking and Reporting
- Improved Supplier Quality
- Robust CAPA Processes
No. Human Factors studies complement but do not replace clinical evaluation. They specifically assess device-user interaction, whereas clinical evaluation assesses clinical performance, safety, and benefits.
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.
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
