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IVDR Technical Documentation

An Overview of IVDR Technical Documentation

IVDR technical documentation is an essential part as it contains the collection of supporting information about your IVD medical device. It should be maintained throughout the product lifecycle. When introducing in vitro diagnostic medical devices on the European market, manufacturers are required to make sure they comply with all applicable regulations outlined in the (EU) 2017/746 In Vitro Diagnostic Medical Devices Regulation (IVDR)

 

Depending on the device’s classification and the conformance evaluation approach selected, a Notified Body may need to evaluate one or more Technical Documentation(s). The guidelines for submitting technical documentation are in line with the criteria of the In Vitro Diagnostic Medical Devices Regulation (IVDR), as outlined in Regulation (EU) 2017/246 in detail in Annex II and Annex III.

 

  • 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)
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The I3CGLOBAL Team assist manufacturers in understanding the complex details of IVD regulations and guarantees that the technical documentation is approved and CE Certification granted faster

IVDR Technical Documentation Requirments

The following are the elements that are elicited in the regulation that we need to mention the details under respective headings in the TD to demonstrate compliance as listed in Annex II of the EU Regulation 2017/746 on IVDR, these requirements are divided into 6 chapters, and the requirements from Annex III on PMS.

 

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

 

Annexe II

  • Device description and specifications, including variants and accessories.
  • Information to be supplied by the Manufacturer – IFU &Labels
  • Design and Manufacturing Information
  • General Safety and Performance Requirements
  • Benefit-risk analysis and Risk Management
  • Product Verification and Validation – Analytical performance, clinical performance, scientific Validity, stability, Usability and Device lifetime
  • Additional Information in other cases like sterilization, Packaging Validation, SSP etc.,

 

Annexe III

  • Post-marketing Surveillance or
  • PMPF
  • PMSR (For classes A and B), and PSUR (For Devices C and D )
  • Vigilance system

 

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.

IVDR Technical Documentation and GSPR

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

Frequently Asked Questions

Stability test of IVD Device and Stability test of specimen is mandatory in Technical Documentation?

Yes, both are mandatory.  Accelerated data is insufficient to support claims.

Information to be supplied by the manufacturer. What all should be included?

It Includes all your primary and secondary labelling and User manual /IFU) and any marketing material that makes claims. Claims need to be supported by evidence. See Article 7 of the IVDR.

Reference to previous and similar generations of the device. What all should be included?

This provides a history of your device lifecycle and helps the notified body understand how relevant evidence relates to the current device and claims.

Design information. What all should be included?

Notified bodies need all details relevant for a basic understanding of design and manufacture.

Benefit-risk analysis and risk management. What all should be included?

These should be live documents, showing the efforts to continually understand and mitigate risks while ensuring the device remains in compliance

Information on analytical performance of the device. What all should be included?

Ensure you have performance study reports and evaluations in the technical file that clarify how the results of analytical studies support the intended use.

Information on clinical performance and clinical evidence (performance evaluation report). What all should be included?

The performance evaluation report (PER) provides evidence on scientific validity, analytical performance and clinical performance to demonstrate a favorable risk-benefit of the device.
Buy Risk Analysis Procedure & Templates

Very useful for small and medium size medical device manufactures

IVDR Performance Evaluation Checklist

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