Follow Us:

I3CGLOBAL

Regulatory Consulting Services

Home IVDR Technical Documentation
Quick Contact
Need Help?
Declaration Of Conformity (DOC)
IVDR Codes
IVDR Technical Documentation

IVDR Technical Documentation

All in-vitro diagnostic devices, irrespective of classification and risk level, require the following elements in the IVDR technical documentation:

 

  1. IVDR 2017/746, Annex II: Technical Documentation, covering design, manufacturing, verification, validation, and risk management
  2. IVDR 2017/746, Annex III: Post-Market Surveillance (PMS)
  3. IVDR 2017/746, Annex XIII, Performance Evaluation Report (PER)

 

The information provided in the technical documentation and performance evaluation report should provide evidence that the General Safety and Performance Requirements (GSPRs), described below,

  • The GSPRs detail the criteria manufacturers must meet to establish performance, associated risks, and design elements.
  • Identification of European Harmonized Standards
  • Annex I, Section 3 of the IVDR states that risk management is “a continuous process throughout the entire lifecycle of a device, requiring regular systematic updating.
  • Post Market Surveillance (PMS) section mentioned in IVDR Annex III, Section 1(a), the manufacturer’s plan to collect and assess post-market data based on a yearly plan covering serious
  • incidents, complaints, public information on other similar medical devices, and more.
  • The post-market performance follow-up (PMPF Plan) is a subset of your PMS plan and is made in line with the results of risk management and product performance.
  • Class A and B manufacturers must prepare a PMSR based on data collected from the market.
  • Manufacturers of Class C and D devices are required to prepare a Periodic Safety Update Report (PSUR) for each device. The PSUR must be updated at least annually. Class C and D manufacturers must submit PSUR to the notified body during technical documentation file submission initially and upon request during additional years.
  • Performance Evaluation Report (PER) as per Annex XIII must be submitted along with technical documentation.

Support from experienced IVDR Consultants is essential, even if the employees are experienced with IVDD.

IVDR Technical Documentation Requirements

The 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 the Global Harmonization Task Force (GHTF).
  • IVDR technical files should be prepared by manufacturers, regardless of the risk class of the device or the notified body. Contact CE-marking consultants with rich experience.
  • IVDR technical documentation is going to be needed at some point for all devices.

 

The IVDR technical documentation should be handed over to competent authorities when requested, so a final version must always be kept with E.A.R. (EU IVDR).

 

Article 11 (3) and “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 and technical files at any time after the assessment by the notified body (EU IVDR Annex IX, Chapter II).