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 FDA requires analytical and clinical validation data under 21 CFR Part 809 and relevant guidance documents, generally submitted through a 510(k), De Novo, or PMA pathway, whereas IVDR requires a Performance Evaluation Report following Annex XIII for CE marking.
Yes. According to MDR and IVDR requirements, the EC REP’s name and address must be clearly visible on the product labeling, outer packaging, or accompanying documents, allowing EU authorities to easily identify the representative.
Yes. Under Regulation (EU) 2017/746, every IVD device, regardless of risk class, must have a Performance Evaluation Report supported by adequate analytical and clinical performance data before CE marking.
Common parameters include trueness, precision (repeatability and reproducibility), analytical sensitivity, analytical specificity, limit of detection and quantitation, linearity, cut-off values, carry-over, and stability.
IVDR requires manufacturers to demonstrate scientific validity, analytical performance, and clinical performance, as outlined in Annex I (GSPR 9-13) and detailed further in Annex XIII.
