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In Vitro Diagnostic Regulation (IVDR)

In Vitro Diagnostic Regulation (IVDR) is the new EU requirement for placing In-Vitro Diagnostic medical devices on the European market.

 

IVDR will replace the EU’s current Directive on In-Vitro Diagnostic (98/79/EC).

 

need to adhere to IVDR by May 26, 2022. IVDR compliance requirements are different from the previous directive and these changes require a more thorough approach to ensure that claims are accurate and devices are safe.

IVDR Technical Documentation

IVDR Technical Documentation / Technical File

New European Union IVDR regulation described in article 10 (4), Technical File is a mandatory requirement for all manufacturers applying for IVDR CE Certification with any Notified Body.

IVDR Technical Documentation as per annex II is based on STED, developed by Global Harmonization Task Force (GHTF).

 

IVDR Technical File should be prepared by manufacturers regardless of the risk class of the device or which Notified Body.

 

The Technical Documentation is going to be needed at some point for all devices.

 

The Technical Documentation should be handed over to Competent Authorities when requested, so a final version must be always kept with E.A.R (EU IVDR Article 11 (3) and with “Person responsible for regulatory compliance” in the manufacturing location (EU IVDR Article 15-3)
The CE Certified IVD manufacturers must keep up-to-date technical documentation / Technical Files any time after the assessment by the Notified Body (EU IVDR Annex IX chapter II).

IVDR Technical Documentation & Consultants Role

  • Confirmation of Device Class and requirement identification for the Technical Documentation,
  • Review of Device Intended use and Specification,
  • Review of Design Files and approval records,
  • Review and guidance for Benefit Risk Analysis,
  • Support in the development of Performance Evaluation Reports,
  • Support in Post-Market Performance Follow-up (PMPF) Plan,
  • Documenting General safety and Performance Requirements (GSPR),
  • Review of Verification and Validation reports.

In-Vitro Diagnostic Device Confirmation as per IVDR

According to EU IVDR 2017/746, In-vitro Diagnostic Medical Device is any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system,

 

Whether used alone or in combination, intended by the manufacturer to be used in-vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or mainly for the purpose of providing information on one or more of the following:

  1.  regarding a physiological or pathological process or state;
  2.  regarding congenital physical or mental impairments;
  3.  regarding the predisposition to a medical condition or a disease;
  4.  to establish the safety and compatibility with potential recipients;
  5.  to forecast treatment response or reactions;
  6.  to define or monitoring therapeutic measures.

CLASS A

To be added

CLASS B

To be added

 

CLASS C

To be added

CLASS D

To be added