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White Paper: Technical Documentation Under the IVDR

What has changed compared to the IVDD, and how can existing technical documentation be adapted in a structured manner? This white paper guides you from conducting an initial assessment to closing identified GAPs - available only in German.

 

What It's All About

Translating IVDR Requirements into a Clear Documentation Structure

The IVDR defines the contents of the technical documentation much more specifically than the previous directive. At the same time, it places greater emphasis on risk management, usability engineering, performance evaluation, and PMS and PMPF. For manufacturers, this means that existing documentation must not only be supplemented but also reviewed in terms of how its various components interact.

This white paper shows how you can first organize your products effectively, systematically evaluate the documentation against Annexes I through III of the IVDR, and use this to develop a robust approach for further processing.

This white paper is not a general list of measures, but rather a technical framework that allows you to systematically classify the actions required for your products.
Available only in German.


Prepared by the IVD expert team at Metecon

 

whitepaper-ivdr-metecon

 

Here's what you can expect

From New Requirements to Ongoing Maintenance

The white paper combines the regulatory framework with a concrete process model for existing products.
01

Changes Under the IVDR

Classification of the new and expanded requirements regarding the content, structure, and updating of technical documentation.

02

Organize Products Effectively

Check the intended use, product description, classification, and essential safety and performance requirements.

03

Structuring a GAP Analysis

Review technical documentation, clinical evidence, performance evaluation, and post-market documentation for completeness.

04

Close GAPs in order of priority

Classify missing or insufficient documentation and plan the processing accordingly.

05

Understanding Technical Content

Guidance on product descriptions, manufacturer information, design, manufacturing, risk management, and verification and validation.

06

Keep Documentation Up to Date

Incorporate product changes, new regulatory requirements, and findings from post-market surveillance into ongoing maintenance.

IVDR White Paper

Questions About the White Paper and Download

Who is the white paper “Technical Documentation Under the IVDR” intended for?

This white paper is intended for manufacturers of in vitro diagnostic medical devices, particularly those responsible for regulatory affairs, quality management, development, and clinical affairs. It helps teams systematically review the technical documentation for their existing products and revise it to comply with the transition from the IVDD to the IVDR.
What topics does the white paper cover?

The white paper covers everything from verifying the intended use and classification, through GAP analysis, to closing identified gaps. It explains the content and structure of the technical documentation, as well as its relationship to risk management, performance evaluation, and post-market surveillance. Sample overviews help users map requirements to existing supporting documentation. The publication is current as of September 2024.
How do I get the white paper?

Fill out the form on this page. You will then receive an email with a link to the PDF. You can download the white paper, access it again later, and share it with your colleagues. If you don't receive the email, please check your spam folder.