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:
-
Demonstrates Compliance: It proves that the device meets General Safety and Performance Requirements (GSPR) outlined in IVDR Annex I.
-
Notified Body Review and Approval: Without TD, the manufacturer cannot obtain or maintain CE Certification.
-
Ensures Transparency & Traceability: Authorities, Notified Bodies, and Competent Authorities can review it during conformity assessments, audits, or inspections.
-
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.
-
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
-
Classify device (A, B, C, D).
-
Implement ISO 13485 QMS.
-
Prepare Technical Documentation & Performance Evaluation.
-
Undergo Notified Body review + onsite audit.
-
Obtain CE Certificate → Affix CE Mark → Maintain compliance via PMS.
service related FAQ’s
Key standards include:
-
ISO 62366-1 – Usability engineering for medical devices.
-
ISO 14971 – Risk management for medical devices.
-
IEC 60601-1-6 – Usability requirements for medical electrical equipment.
-
ISO 20916 – Performance studies for IVDs.
Absolutely. We can take over Post Market Clinical Follow Up 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.
A Biological Evaluation Report (BER) summarizes the device’s biological risk assessment, including device description, material characterization, exposure categorization, literature review, testing results (if applicable), and a toxicological risk assessment. It concludes whether the device is biologically safe and compliant with ISO 10993.
Yes, GMP compliance is mandatory for medical device manufacturers who market products in the United States. The FDA enforces GMP through the Quality System Regulation (21 CFR Part 820), which outlines the minimum requirements for design, production, labeling, packaging, and storage of medical devices to ensure safety and effectiveness.
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.
