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
After Brexit, UKCA replaced CE marking in Great Britain. Manufacturers must comply with MHRA rules to legally place devices on the UK market.
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.
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.
Yes. We help you identify the most suitable Notified Body based on your device type, risk class, and review timelines and support you throughout the submission and technical documentation review process.
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
